Quality Assurance | Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance

Responsibilities of Pharmaceutical Quality Assurance Department

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

HVAC validation