Quality Assurance Manager

Job Description

To ensure the implementation of cGMP by the help of Standard Operating Procedures, Standard Test Procedures, Specifications, Validation protocols, Stability protocols, Master Batch Production records etc. Approval of SOPs, Protocols, Formats, reports and other GMP documents for all functions viz. QA, QC, Maintenance and Engineering, Production, and Warehouse. To implement good documentation practices. To release the finished products and to ensure the completeness of batch manufacturing and packaging records. Market complaint investigation in accordance with company guidelines and external regulatory requirements. To ensure appropriate disposition of incidents / OOS / OOT and approval of deviations. Review and approval of the Validation Master Plan, Site Master File, Annual Product Quality Review, annual planners and other documents related to QAD. To develop, implement, and manage processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery. To ensure the handling of non-conformity as per defined procedure. To approve and maintain the artworks and shade cards. To ensure the handling of quality management system as per defined procedure. To ensure the thorough investigation of deviations and conclusion in accordance with cGMP. Review deviation reports and ensure that corrective and preventive actions (CAPA) are implemented satisfactorily. To ensure that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements. To conduct regular internal audits and planning of self-inspections of the manufacturing facility to ensure that the facility meets the required quality standards. Also handle the external audit and its compliance. To ensure that products are released only after they have met the required specifications and are deemed safe and effective. To approve aseptic process simulation study protocol and report. To approve all qualification / re-qualification protocols and reports. Involved in qualification process of new manufacturer / supplier / vendor meant for raw material, primary packing material or secondary packing material. To assign responsibilities and tasks to the assigned persons as per their qualification, experience and competency.