- Well versed with Pharmaceutical Sterile Manufacturing procedures, Deviation Management, CAPA, OOS, OOT, Change Management, Risk Management, Data Integrity, APQR, HVAC System, Water System and other key activities and quality assurance procedures.
- Develop new QMS (Quality Management System) documentation & procedures working closely with other members of team.
- Maintain track of Quality Assurance activities within the scope of his/her responsibility.
- Prepare and review the protocols and reports. Execution of various qualification / validation activities including equipment, facility, process, systems & cleaning validation etc.
- Perform Impact Assessment, Risk Assessment of equipment, facility, system, and process.
- Review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ, FAT).
- Co-ordinate with production and other user department for qualification/validation activities and other key activities at site, as advised by superiors.
- Timely compile and review of QMS documentation.
- Review the equipment documents like calibration reports and ensure correctness of documents.
- To co-ordinate with outside agencies for execution of qualification / validation activity whenever required.
- Identification of deviation through review and observation.
- Prepare annual Re-qualification/validation, calibration schedule, update VMP and Qualification related documents
- Review and update SOPs as and when required.
- Review of day to day quality compliance and help to develop a QUALITY mind-set across the site.
- Highlighting quality non-compliance issues to superiors & ensuring timely Corrective & Preventive Actions for observed non-compliance.
- Taking lead during external client audits.
Chia sẻ
Bình luận