Purpose

To support Lab (Analytical) for maintaining Quality and compliance as per the GMP norms

Position / Job Title

Executive

Department

Quality Assurance – Analytical Lab Quality Assurance

Reporting To

Senior General Manager –Quality Assurance

Location

Pithampur

Years Of Experience

6 Years to 8 Years

Dosage Form

Solid Oral / Cream and Ointment 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.

Review 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/Post graduate 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 (preferred)

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.