- To perform all the activities of Quality assurance departments.
- Ensure that SOPs are available for all quality related activities and they are current.
- Prepare and review all quality assurance related documents such as SOPs, log book, format, etc.
- Responsible for the Release of the final products.
- Review batch sheet, packing sheet and final product release document.
- Ensure the implementation of Valuable manufacturing practices.
- Ensure implementation of documentation system in the Quality control, Quality Assurance, Production, Engineering, Ware House, and other relevant departments.
- Ensure retention of all records relating to the manufacture, testing and packaging of the products.
- Prepare department organogram.
- Issuance of all quality assurance related document and also manage record for retrieval record for document.
- Prepare the annual product quality review for the entire product.
- Prepare the SOP and format related quality assurance department.
- Review of deviation and change control activities and issuance of related document.
- Prepare the internal audit document as per schedule and necessary corrective & preventive action is taken.
- Act as quality representative for Quality related activities.
- Responsible to maintain the stock of QA department.
- Responsible to give GMP training.
- Responsible for new employee training.
- Review vendor qualification document.
- To participate in equipment qualification and process validation programme.
- To undertake any other job as may be assigned by the Lead quality assurance.
- Review the deviations and OOS are investigated and necessary corrective and preventive actions are implemented
- Responsible to maintain AVL and coding list.
- Responsible to fill vendor qualification documents and give response to vendor query.
- To prepare internal audit schedule and to implement.
- To prepare training schedule and its effectiveness.
- Responsible to review of finished product analysis data.
- Responsible to take follow up for calibration, maintenance schedule.