Quality Assurance Manager

To check and monitor the GMP and GLP compliances.

Dispatch of goods from plant - completion of all documentation and give the batch release

To be responsible for overall quality assurance functions in the factory.

To approve and monitor all SOPs related to QA, QC, Production, stores, Admin and Engineering departments.

To approve all specifications of Raw Materials, Packing Materials, Intermediates and Finished Goods.

To review and approve Validation Master Plan, Master Formula Records, Master BMR, Master BPR, Site master files.

To approve and monitor all process validations, Cleaning validations, Hold Time Studies, Validations of premises, equipment and procedures.

To approve the stability programme and procedure.

To carry out the internal and external audits and to monitor the compliances of regulatory audits.

To release the finished product after verifying the Batch manufacturing and packing records, analytical records and other related documents thereof.

To design and approve the training schedule & impart training to all personnel.

To check and approve the preventive maintenance schedule.

To check for the sanitation of premises and equipment, hygiene & housekeeping of factory.

To check and approve deviations, change controls, OOS, Investigation reports, all IPQA records and annual product reviews.

To handle market complaints, FDA related matters and FDA complaints, product recalls and quality management systems activities.

To monitor compliances for systems and documents and ensure all legal standards are met.

To monitor the effectiveness and efficiency of HVAC, water system, Compressed air and all utilities used in the manufacturing of products.

To monitor the formulation development and technology transfer activities from R&D and ADL

To Confirm Quality Assurance at every stage of Product Processing.

Responsible for handling and monitoring of control samples and upkeep of control samples room.