AddressQuality Analyst III
Who we are
How you’ll spend your day
1) Review / Approval of Nitrosamines related documents.
- Analytical Development Report,
- Method Validation Protocols and Reports.
- Nitrosamine risk assessment
2) Review / Approval of Computer System Validation related activities in gALM.
3) Release / Reject of batches manufactured for clinical study.
4) Review / Approval of Qualification documents for new instrument/ equipment.
5) Implementation of Corporate policies / standards at site.
6) Review, evaluation and approval of QMS documents i.e. change controls / deviations / LIR / chromatographic errors etc.
7) Review / approval of Investigations, CAPA, LIR in Trackwise system.
8) Ensure CAPA actions based on the investigation root cause are identified and implemented.
9) Preparation of trends for non–conformance.
10) Self-inspection of various departments to check compliance with GxP, SOPs and applicable regulatory requirements.
11) Compilation of Site Quality Council Report and presentation of data on monthly basis.
12) Review of Risk Assessments, Quality Technical Agreements between Teva and various contract laboratories, Intra Company- Quality Technical Agreement (IC-QTA).
13) Review / Approval of specifications, Method Validation Protocols / Reports, Method Transfer Protocols / Reports, ADR, PDR, Study Protocol / Reports etc.
14) Perform audit of Contract Laboratories, Third party vendor in co-ordination with Subject Matter Expert.
15) Support during regulatory and other inspections at site.
16) Any other responsibilities assigned by Head of Quality
Your experience and qualifications
- M Pharm/ B Pharm/ M Sc
- 10 plus years relevant experience in Quality & Analytics
- Must have experience in QMS.
