Current Openings Shilpa Medicare Ltd

Rahul Kashyap
0


Quality Control

Position Title : Chemist / Executive / Sr. Executive

Education Qualification : B.Sc/M.Sc (Chemistry)

Experience : 5-8 Years experience.

Job Description

  • Responsible for allocation and review of analysts work against standards.
  • Maintaining RM control samples, performing routine analysis and reporting test results, conducting internal audits and preparing trend reports.
  • Taking necessary investigative measures for out-of-specification laboratory results and facilitating achievement of production schedules.
  • Responsible for staff development through proper induction and training.
  • Analytical experience in the pharma industry will be preferred.
  • Should be well versed with QC activities of API in process labs.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired
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Quality Assurance

Position Title : Manager QA

Education Qualification : B.Sc/M.Sc (Chemistry)

Experience : 10 - 15 Years experience.

Job Description

  • Follow up with Regulatory Audits and Customer Audits.
  • Reviewing all Regulatory documents prior to submission to Regulatory Affairs Department.
  • Implementation of Quality Management System across the site.
  • Data review and submission to RA for DMF deficiencies.
  • Investigations are carried out during Batch deviations, OOS results and customer complaints.
  • Validation Master Plan, Validation Protocols Validation Reports and qualification documents
  • Approving changes to the existing systems, documents, processes, specifications and test methods of Raw materials, Intermediates and Finished Products.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired


Quality Assurance

Position Title : Executive / Sr Executive

Education Qualification : B.Sc/M.Sc (Chemistry)

Experience : 5 - 8 Years experience.

Job Description

  • Review process documents stage-wise and facilitate timely release of batches.
  • Perform IPQA checks during production.
  • Review and compile deviations and change controls.  Ensure quality compliance of the product through internal audits.
  • Knowledge of SOP's and IPQA processes and exposure to external audits.
  • Experienced candidates from Pharmaceutical / Chemical Industry preferred.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired.
Apply Here

Production

Position Title : Executive / Sr Executive

Education Qualification : B.Sc/M.Sc MSc (Org. Chemistry)

Experience : 8 - 12 Years experience.

Job Description

  • Execute the production plant as per shift operations to achieve consistent product quality, quantity and yield.
  • Trouble shooting of process and operational issues on shop floor.
  • Supervise batch charging and verification of RM Quantities and responsible for maintaining Batch Production records.
  • Check equipments and connected accessories and operate them as per the process norms.
  • Monitor and maintain all parameters as per SOPs and ensure strict compliance with GMP and safety norms
  • Experienced candidates from Pharmaceutical / Chemical Industry only may apply.
  • Knowledge of SOP's and manufacturing processes will be an added advantage.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired
Apply Here

Production

Position Title : Chemist /Sr. Chemist

Education Qualification : B.Sc/M.Sc 

Experience : 2-8 Years experience.

Job Description

  • Job Description: Supervise batch charging and verification of RM Quantities and maintain Batch Production records.
  • Check equipments and connected accessories for cleanliness and operate them as per the process norms.
  • Monitor and maintain all parameters as per SOPs and ensure strict compliance with GMP and safety norms.
  • Seek assistance for or escalate all process deviations/maintenance jobs. Experienced candidates from Pharmaceutical / Chemical Industry only may apply.
  • Knowledge of SOP's and manufacturing processes will be an added advantage.
  • Experience in manufacturing processes such as compression, granulation, coating, capsule filling will be an added advantage.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired.
Apply Here

Maintenances

Position Title : Asst Manager-Electrical

Education Qualification : BE, Electrical/Electronic

Experience : 8 - 10 Years experience.

Job Description

  • Responsible for providing services of utilities to the plant.
  • Responsible for ensure that Devices /instruments used in the plant are calibrated as per calibration schedule plan and to review the relevant records.
  • Responsible for ensuring the production equipment’s are suitable for the purpose intended and are maintained in order.
  • Responsible for procuring various equipment’s and services from out side agencies.
  • Responsible to reviewing of all maintenance related records and ensure document completeness.
  • Responsible for monitoring preventive maintenance activities and review records.
  • Responsible to ensure the building maintenance with coordination of production people.
  • Responsible to monitor the cleaning of water pipe lines, storage tanks, DM plant and AHU filters.
  • Responsible to perform training programs related to maintenance department staff and employees as per schedules
  • Responsible to ensure that the employees working in maintenance department are aware of all procedures and systems in the company. follow the standing orders of the company as well change in company policies are to be adopted regularly.
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Maintenances

Position Title : Executive

Education Qualification : BE, Mechanical/Diploma Mechanical

Experience : 5 - 7 Years experience.

Job Description

  • Responsible for perform the Devices /instruments used in the plant are calibrated as per calibration schedule plan and to review the relevant records.
  • Responsible to follow up the prepare and review of all related maintenance records ensure that are completed and signed. preventive maintenance activities and maintain records. the cleaning of water pipe lines, storage tanks, DM plant and AHU filters.
  • Responsible to perform training programs related to maintenance department staff and employees as per schedules.
  • Quality Control

    Position Title : Sr Chemist/ Executive– Quality Control- GCMS

    Education Qualification : M.Sc (Chemistry)

    Experience : 3 - 6 Years experience.

    Job Description

    • Candidate should have experience in handling the GCMS
    • Performing routine analysis along with having knowledge of method development and validation, conducting internal audits and preparing trend reports.
    • Responsible for staff development through proper induction and training.
    • Analytical experience in the API Pharma industry.
    • Should be well versed with QC activities of API.
    • Exposure to regulatory audits
    Apply Here

    Quality Control

    Position Title : Microbiologist/ Sr Microbiologist

    Education Qualification : M.Sc (Microbiologist)

    Experience : 2 - 5 Years experience.

    Job Description

    • Microbial limit test analysis for raw material, finished products, stability samples and packing material.
    • Responsible for Bacterial endotoxin test for raw material and finished products.
    • Experience in Identification of Standard organisms and in-house isolates  up to species level using BBL or other suitable instruments
    • Disinfectant Efficacy study
    • Investigation and reporting of Out of Specification, out of alert , out of action , Out of trend ,Deviation or Incidence observed during the activity.
    • Responsible for operation of Incubators, cooling cabinets, plasma freezer and Duo Block Incubator, Laminar air flow, Bio-safety cabinet, Garment storage cabinets, ceiling suspended laminar air flow, water bath, dynamic pass boxes, colony counter and static pass boxes.
    • Operation of Horizontal autoclave, vertical autoclave, Depyro oven, Hot air oven and Heat Seal machine.
    • Preparing and updating of all sops, specification, test methods validation protocols, study protocols and reports.
    • Environmental monitoring, media preparation activity.


    Quality Assurance

    Position Title : Executive/Sr Executive

    Education Qualification :  B.Sc/M.Sc (Chemistry)

    Experience : 5 - 8 Years experience.

    Job Description

    • Review process documents stage-wise and facilitate timely release of batches.
    • Perform IPQA checks during production.
    • Review and compile deviations and change controls.  Ensure quality compliance of the product through internal audits.
    • Knowledge of SOP's and IPQA processes and exposure to external audits.
    • Experienced candidates from Pharmaceutical / Chemical Industry preferred.
    • Exposure to regulatory audits and eagerness to work on the shop floor is desired
    Apply Here

    Production

    Position Title :  Chemist / Sr. Chemist

    Education Qualification : B.Sc/M.Sc

    Experience : 2 - 5 Years experience.

    Job Description

    • Job Description: Supervise batch charging and verification of RM Quantities and maintain Batch Production records
    • Check equipment’s and connected accessories for cleanliness and operate them as per the process norms.
    • Monitor and maintain all parameters as per SOPs and ensure strict compliance with GMP and safety norms.
    • Seek assistance for or escalate all process deviations/maintenance jobs. Experienced candidates from API Pharmaceutical / Chemical Industry only may apply.
    • Knowledge of SOP's and manufacturing processes will be an added advantage.
    • Exposure to regulatory audits and eagerness to work on the shop floor is desired.


    Safety

    Position Title :  Asst Manager/ Dy Manager-Safety

    Education Qualification : Graduate/ PG in science, engineering, chemistry

    Experience : 15 + Years experience.

    Job Description

    • Ensuring the safety operations in the plant, following the guidelines OSHAS, by implementing work permit systems.
    • Identifying the unsafe practices and plugging them, monitoring of safety procedures implementation. Evaluating the safety procedures, and formulating the safety procedures to ensure zero accidents.
    • Responsible for maintenance of statutory records and meet the requirements of statutory documentation and maintenance of records and submission of returns and compliance under various acts of State & Central Govt as applicable.
    • Responsible for maintenance of records as per GMP requirements .
    • Responsible for staff development through proper induction and training
    Apply Here

    ADL

    Position Title :  Chemist/ Sr Chemist/ Executive

    Education Qualification : M.Sc /M Pharm(Chemistry)

    Experience : 3 - 6 Years experience.

    Job Description

    • Candidate should have good knowledge of Analytical Chemistry
    • Candidate should have experience in handling either of HPLC/ GC/ LCMS/ GCMS/ ION Chromatography, XRD and Particle size analysis
    • Performing routine analysis alongwith having knowledge of method development and validation,
    • Good experience in handling of standard and qualification
    • Responsible for staff development through proper induction and training.
    • Analytical experience in the API /Pharma industry will be preferred.
    • Exposure to regulatory audits and eagerness to work on the shop floor is desired

ENGINEERING


Section : Process

No. Of Positions : 1

Position Title : Dy. Manager

Experience : 12 - 15 Years experience

Job Description :

Team Handling, QMS, Hands on Experience in Handling all process Equipments like Vial washing machines, Filling Machines, Autoclaces, Must be from electrical / Mechanical Back ground.


Section : Process

No. Of Positions : 1

Position Title : Asst. Manager

Experience : 9 - 11 Years experience

Job Description :

Team Handling, QMS, Hands on Experience in Handling all process Equipments like Vial washing machines, Filling Machines, Autoclaces, Must be from electrical / Mechanical Back ground. Must be ready for Shifts Handling.
Apply Here

Section : Injectable Process

No. Of Positions : 8

Position Title : Officer / Executive

Experience: 2 - 7 Years experience

Job Description :

Hands on Experience in Handling all process Equipments like Vial washing machines, Filling Machines, Autoclaces & Isolators Must be from electrical / Mechanical Back ground. Must be ready for Shifts Handling.
Apply Here

Section : OSD Process

No. Of Positions : 3

Position Title : Officer / Executive

Experience : 2 - 7 Years experience

Job Description :

Must be having hands on experience on all OSD Process equipments (Ganulation, Compression,Coating Machines) and knowledge on Packing Machines. Must be ready to work in shifts.
Apply Here

Section : QC / QA / Micro Maintenance

No. Of Positions : 2

Position Title : Officer / Executive

Experience : 2 - 7 Years experience

Job Description :

Must be having hand on Experience in handling Stability chambers , Cooling Chambers , Autoclaves and QC / QA Related Equipments.
Apply Here



PRODUCTION (INJECTABLES)


Section : Vial washing & depyrogenation tunnel

Position Title : Operator / Supervisor

Experience : 3 - 6 Years experience

No. Of Positions : Operator - 4, Supervisor - 7

Job Description :

Must be worked and should handle vial washing machine and tunnel sterilizer, should aware about the trouble shooting of these machines.


Section : Compounding

Position Title : Operator / Supervisor

Experience : 3 - 6 Years experience

No. Of Positions : Operator - 4, Supervisor - 6

Job Description :

Should know the CIP/SIP of compounding and filtration vessels, should performed the compounding/ manufacturieng of batch through isolator technologies. Also able to handle thetemperature, PH and DO sensors and offline PH, DO and conductivity meter.


Section : Component preperation & sterilization area (Autoclave)

Position Title : Operator / Supervisor

Experience : 3 - 6 Years experience

No. Of Positions : Operator - 3, Supervisor - 3

Job Description :

Must be aware about the operation and cleaning of Autoclave equipment and its troubleshooting, should know about the differnet load preparations (like filling load, filtration load, Rubber stopper load, seals load etc). Also must be aware about the preparation of Disinfectant solution preparation and its usage and distruction.
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Section : Wash area (GMP washer/clean equipment hold room)

Position Title : Operator / Supervisor

Experience : 3 - 6 Years experience

No. Of Positions : Operator - 1, Supervisor - 1

Job Description :

Should aware about the cleaning procedure of equipment/ accessories after its usag (manually and automatically in GMP washer equipment) should aware about the shoe cleaning procedure.


Section : Filling, Filtration and Sealiing area

Position Title : Operator / Supervisor

Experience : 3 - 6 Years experience

No. Of Positions : Operator - 14, Supervisor - 6

Job Description :

Person must be expert in aseptic practices, critical gowining procedures, aseptic assembling of filtration and filliing machine, operatin of filling and sealing machine. He should aware about the handling of isolator technologies, aseptic cleaning practices in critical areas, should aware about the filtration process .
Apply Here

Section : External vial washing and Terminal sterilization area

Position Title : Operator / Supervisor

Experience : 3 - 6 Years experience

No. Of Positions : Operator - 3, Supervisor - 3

Job Description :

He should know the handling of external vial washing machine (external decontamination machine) should know the isolator technologies. Also know about the batch number coding procedure on vials (inkjet printer operation) as well as leak test procedure of filled and sealed vials.
Apply Here

Section : Lyophilization area

Position Title : Operator / Supervisor

Job Requirements : 3 - 6 Years of working experience

No. Of Positions : Operator - 2, Supervisor - 3

Job Description :

He should have deep knowledge of lyophilizer and must handle trouble shooting of lyohilizer in operation he must be know the CIP, SIP, Leak tesing Lyophilization process, de-icing process.

Purchase

Job Title :Purchase - AM/Sr.Executive/Executive – Pharma/Biopharma

No. Of Positions : 5

Job Requirements :

  • Looking for candidates with Pharma Work experience.
  • Having 2-5 years experience in procurement. (Lab Chemicals and consumables, Engineering, Maintenance, civil, General Consumables, stationery, Safety Items)
  • Should be from Pharma background
  • Knowledge of Tally and preparation of PO in SAP and its distribution
  • Knowledge of MS office

Job Description:

  • Internal Co-ordination with Stores, Finance & user dept. for daily activities like receipt of material, payments to vendor.
  • Daily review of indents, Keep track and update status to end user on weekly/monthly basis or as and when required, seek clarifications of requirement from the end user.
  • Preparation of comparative statement & Purchase Orders.
  • Bill forwarding to finance for payment.
  • Co-ordination for collection of Material from Transport godown along with store person.
  • Routine follow up for purchase order-delivery of materials.
  • Keeping track of payment.
  • Reporting to HOD for daily activities.

Cell Culture (R&D Biologics)

Job Title : Purchase - Cell Culture (R&D Biologics) - Associate Scientist / Scientist

Experience : 4 - 5 Years of working experience in Pharma Industry

Education : Bachelor's (Preferred)

No. Of Positions : 3

Job Type : Full-time

Job Description :

  • Hands-on experience in cell line maintenance (CHO-S, CHO DG44 and/or Sp2/0), cell banking, revivals
  • Hands-on experience in Cell line development - transfections (chemical/electroporation), clone selection, media optimization, development of high expressing stable clones expressing Mab, fusion proteins and glycoproteins.
  • Be able to interface with the analytical group for clone selection and establishment of quality parameters
  • Experience in Clean Room processes and documentation.
  • An individual will also be expected to document work in the laboratory notebook.
  • Leadership - Ability to lead a team of 2-3 members and hands-on experience in DoE will be a definite plus.

Upstream Process Development - Mammalian

Job Title:Upstream Process Development (Biopharma) - Sr. Manager/Manager/DM

Job Description :Sr. Manager/Manager/DM Upstream Process Development

No. Of Positions : 1

Description :

  • 8-10 years experience in RnD, in CHO cell line based MAbs/fusion proteins/Glycoproteins upstream process development that includes
  • Scales between 15ml (Ambr), 2-10L glass bioreactors (Sartorius, NBS etc) and 50L SUB (Sartorius, Pall, GE)
  • Cell revival, banking, seed preparation, media/additives preparation
  • Bioreactors setup, sampling, sample analysis
  • Should have managed team of 6-10 RnD staff, including training/documentation
  • Well versed with clean room techniques, RnD Bioreactor setup and GLP documentation processes
  • Technology transfer experience to Manufacturing will be a definite advantage
  • Hands-on experience with DoE software will be a definite advantage
  • Candidates to highlight achievements in above areas.

Upstream Process Development - Mammalian

Job Title : Upstream Process Development - Mammalian (Biopharma) - Sr. Research Associates/Asst-Managers

Experience : 4 - 6 Years of working experience

Education : Bachelor's (Preferred)

No. Of Positions : 3

Job Type : Full-time

Job Description :

  • 4-6 years experience in RnD, in CHO cell line based MAbs/fusion proteins/Glycoproteins upstream process development that includes
  • Scales between 15ml (Ambr), 2-10L glass bioreactors (Sartorius, NBS etc) and 50L SUB (Sartorius, Pall, GE)
  • Cell revival, banking, seed preparation, media/additives/buffer preparation
  • Bioreactors setup, sampling
  • Should have managed team of 2-4 RnD staff
  • Well versed with clean room techniques, RnD Bioreactor setup and GLP documentation processes
  • Hands-on experience with DoE software will be a definite advantage
  • Candidates to highlight achievements in above areas.
  • Research,Technology Transfer,Process Development,scale up,pilot scale,CHO cells,MAbs,Upstream,Mammalian Cell Culture,GLP,glycoprotiens,Fusion protiens


Analytical Development

Job Title : Analytical Development (Biopharma) - Sr.research Associate / Scientist

Experience : 2 - 5 Years of working experience

Education : Bachelor's (Preferred)

No. Of Positions : 3

Job Type : Full-time

Job Description :

  • Method Development for in-process characterization/estimation of yields of MAbs / fusion proteins / Glycoproteins
  • Hands-on experience with PAT tools, Analysis, and de-bottlenecking of processes developed results obtained
  • Should have worked closely with process groups (Upstream, Downstream or Formulation Development) on debottlenecking processes being developed for fermentation, purification or formulation of recombinant proteins
  • Hands-on experience in running and analyzing raw data from any of the following - HPLCs (with fluorescence/PDA/UV/QDa detectors), BLI, DSC, CZE, Multimode readers, Fluorescence/IR Spec, multi-chemistry analyzers
  • Maintaining GLP records, identifying and incorporating the latest Process Analytical technologies into development programs for existing and new molecules
Expected to be a team player with potential leadership qualities. Previous experience in the Biopharma Industry is MUST.

Urgent Opening in R&D for Analytical Development!!

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