Quality Assurance | Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance

Responsibilities of Pharmaceutical Quality Assurance Department
Quality Assurance

  • Performing in process Quality Checks to produce defect free product
  • Preparation and revision of Site Master File from time to time.
  • Preparation and review of validation protocol.
  • Adherence to both GLP and GMP
  • Handling of market / customer complaints
  • Preparation Schedule of Calibration & Validation activities.
  • Vendor Approvals for RMs & PMs
  • Handling of External & internal audits
  • Performing Training Programs in coordination with external agencies.
  • Implementation of Quality Management System, related to cGMP.
  • Liasioning with regulatory authorities
  • Authorization of change controls and deviations
  • Preparation / approval / issue and control of QMS documents.
  • To plan, control and review Pharmaceutical Quality Assurance processes
  • To monitor & review product quality and ensure regulatory compliances
  • To initiate actions arising out of quality complaints and to resolve non- conformance.
  • To initiate and oversee product recall.
  • To audit, validate and approve suppliers.
  • To approve and issue the specifications for Finished Product, Raw & Packaging Material.
  • To monitor stability studies.
  • To update the all legal changes with respect to new Pharmacopoeia / addendum.
  • To coordinate in organizing and conducting GMP / ISO training to employees.
  • To release the Finished Products for sale.
  • Release of purchase data / purchase orders and supplier instructions;
  • Evaluation of supplier performances;
  • Internal Audit/Self Inspection
Good documentation practices SOP
Change Control Procedure
Temperature mapping study
Deviation management process
Qualification in pharma
Vendor Qualification 
Site Master File
Pharmaceutical labeling requirements
Standard test procedure in pharmaceuticals
Root cause analysis methods
SOP on Issuance ,retrieval,archival of formats and log books 
SOP on Handling and control of Documents 
SOP on internal and External training Program
Performance qualification of Pharmaceutical equipment
Non Conformance report 
Analytical Method Validation 
Product Complaints 
Line Clearance 
Process Validation Procedure 
Hold Time Study
Sampling Procedure 
Validation Master Plan
Quality Risk Management 
External Audit Process
Management Review meeting 
Cleaning Validation
Product Recall
Out of Trends 
Key Performance Indicators 
Water Monitoring System 
Testing of Raw materials