Piramal Pharma Solutions (PPS)
Designation : Senior Executive
Function : QA
Functional Area : Quality Assurance
Job Role Summary : Analytical QA, Review of Analytical Documents, Instrument Audit Trails
Job Profile :
- Review analytical raw data, electronic data, and audit trails for laboratory instruments. Ensure laboratory compliance with GMP/GxP requirements and established procedures. Investigate and manage QMS events- including OOS, OOT, OOE, deviations, and incidents. Review, approve, and maintain analytical SOPs and quality documents for continual improvement.To carry out activities of Analytical QA personnel.
- Review of analytical raw data and documents.
- Review of electronic data and audit trail for instruments like HPLC, GC-MS, ICPMS, LC-MS, XRPD.
- Monitoring compliance in laboratory as per laid down procedures.
- Investigation of QMS – OOS, Deviation, Incident, OOT, OOE.
- Review of Analytical SOPs for compliance requirements and continual improvement
- Review and approval of analytical documents such as specifications, test procedures, analytical method validation / verification protocols & reports, Analytical method transfer protocols & reports, stability reports, investigation reports, trend reports etc.
- Review and approve the raw material, packing material, finished product analytical data.
- Review of Product development reports.
- Review of computer system validation documents.
- Prepare SOPs related to QA Department.
- Periodic review of analytical records (instrument logbooks, calibration records, standard management records etc.)
- Impart induction training on topics and on which training has been taken.
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
Job Requirements :
- Personnel with Analytical QA background in regulated Pharma, API, Drug Disovery area
Type of Experience : Pharma QA, Analytical QA, QC experience in regulated environment
Academic Qualifications :
Graduates, Post Graduates in Science, Pharmacy
