• Review of validation documents (Mfg. Process, Cleaning, equipment and water validation etc.) and overall monitoring of validation activities. • Responsible for Document Data Control. • Internal Audits. • Co-ordination with other department for cGMP compliances. • Responsible for customer audits and its responses. • Plant Round. • Preparation and Review of Validation Master plan.. • Preparation and Review of site Master file. • Review and evaluation of Change control, Deviations and CAPA. • Handling of Out of Specification, Out of trend and NCR etc.. • Responsible for handling of Market complaints and fulfilment of other marketing requirements. • Handling of returned goods and product recall. • Approval of filled batch process records of intermediates and finished products. • Responsible for batch release. • Review and approval of standard operating procedure for all departments. Preparation, Review of Quality Assurance SOPs. • Review of Quality control compliances. • Reviewing and approval of all BPR/MPR/PQR. • Review and approval of Equipments qualification. • Reviewing and approval of all Master specification, method of analysis, protocol and reports. • Responsible for Vendor Qualification. • Responsible for approval of approved vendor list and updating. • Co-ordinate with local FDA for various FDA related works. • As and when as per requirement other QA works to be done.
