• 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.