Quality Assurance - Manager (Injectable Only)

Role & responsibilities

• Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification / validation, GLP, training activities etc. and responsible for leading and directing QA team
• To approve SMF, VMP, quality manual and validation protocol.
• To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement.
• To arrange management review meeting and escalate the outcome of quarterly report to management.
• To handle the Market Complaints and to participate in Product Recall.
• To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods.
• Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record.
• Responsible to design validation / qualification strategies
• Responsible for validation / qualification of processing equipments, cleaning equipments and testing equipments on time.
• Responsible for day-to-day validation planning and execution activity.
• Responsible to approve specifications, standard test procedures and analytical work records.
• To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports.
• Responsible for regulatory & customer audits preparation, execution and its compliance.
• To approve and authorize technical agreements from customer and outside party.
• Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department.
• Responsible to make the management aware of any deviation / non-compliance or any other quality related issues during validation / qualification & processing.
• To ensure the implementation of quality risk management procedures.
• Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects.
• To ensure that processes needed for the Quality Management System are established, implemented and maintained.
• Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events.
• Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action.
• Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System.
• Responsible to perform vendor audits and internal audits.
• To check audit trial and back-up verification documents.
• Participation in study raised through Quality Management System.

Skills Required

Good Laboratory Practice Glp, Quality Management System, Change Control, Internal Audits, Quality Assurance