Job Description
Purpose
To support Lab (Analytical) for maintaining Quality and compliance as per the GMP norms
Position / Job Title
Senior officer
Department
Quality Assurance – Analytical Lab Quality Assurance
Reporting To
Senior General Manager –Quality Assurance
Location
Pithampur
Years Of Experience
2 to 4 Years
Dosage Form
Solid Oral experience is must
Job Responsibilities / Deliverables Requirements For The Job
Well versed in the analytical review of documents, which includes those from GLP section.
Handling of OOS, OOT, Events, Change control and CAPA.
3Review and ensure compliance of Column management, Standard management, glassware management and chemical management.
Responsible for Retention samples management and review of stability sample and stability study management. To review of stability protocol/summary sheet
Review Computer system validation, calibration & qualification of instruments. Review of audit trails from the computerized systems.
Ensure QC laboratory compliance at all times, participate in Lab check rounds.
Preparation & review of OOS/OOT/Events trending.
Review of analytical documents, chromatograms related to AMT/AMV protocols and reports.
Preparation of SOPs
To review the Analytical reports in support of Batch release activities
To review and approve the batches with generation of Certificate of Analysis for Finished Product
Review Analyst qualification data
Qualifications & Pre-Requisites Must-Have Skills
Should be Graduate/Postgraduate in Science or Pharmacy
Must have knowledge on handling HPLC, GC, KF, Dissolution. FTIR, FTNIR is preferable.
Exposure to various regulatory bodies like US FDA, MHRA, TGA
Exposure to specific dosage forms like OSD.
Expertise in Qualification of CSV instrument documents verification
Expertise in Method validation and Analytical method transfer process
Exposure to expertise towards handling of QMS records
Additional Notes
Role is expected to work in all shifts.
Expected to visit Satara/Thane sites at least twice a month on need basis.
