- To ensure that each batch has been manufactured and packed in accordance with the approved manufacturing and packing procedure, complies with established specification of that product and is in accordance with the requirements of the marketing authorization.
- To approve or reject finished products.
- To oversee the control of the reference and/or retention samples of materials and products wherever applicable.
- Management of the in-process quality assurance.
- To approve DQ/IQ/OQ/PQ data generated for each equipment/instrument/utility used for the manufacturing/packing/testing of finished drug products.
- To approve preventive maintenance/cleaning schedule for building facility/ equipments/utilities prepared by respective department as per cGMP requirement.
- The authorization of written procedures and other documents, including amendments.
- Storage and maintenance of documents/records generated as per cGMP requirements.
- The monitoring and control of the manufacturing environment.
- To ensure that the duly filled batch manufacturing and packaging records received from production department are reviewed and only after review, batch is released for final dispatch.
- Maintenance of plant hygiene.
- Handling of market complaints and returned goods.
- The designation and monitoring of storage conditions for materials and products.
- Retention of records.
- Monitoring of compliance with the requirements of Good Manufacturing Practice.
- Inspection, investigation and taking of samples in order to monitor factors which may affect product quality.
- Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
- To ensure that deviations and planned changes are handled as per the established systems and are authorised by the responsible persons.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Unichem Laboratories Ltd
With formulations constituting the core of the company business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability.
Contact Company:Unichem Laboratories Ltd