Job Description:

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 8years
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/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 (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.

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