Natco Pharma Limited – Urgent requirement for Analytical Quality Assurance (API)

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). Our focus is primarily on niche therapeutic areas and complex products. We market and distribute our products in over 40 countries.

Greetings from Natco Pharma Limited !!

Urgent requirement for Analytical Quality Assurance (API) for our Chemical Division @ Chennai Unit.

Qualification: M.Sc. (Organic Chemistry)

Experience: 4 to 8 Years (API Experience in AQA)

Candidates native of Chennai only eligible to apply for this vacancy

  • Review of intermediate and finished product analytical reports followed by batch release.
  • Review of Certificate of Analysis and handling of dispatch related activities by assessing PO and customer specification requirements.
  • Review of Laboratory investigations OOS/OOT/OOC/Laboratory incidents.
  • Review of deviation investigation reports.
  • Handling of Change Management, assessing the impact of change and approval of change controls.
  • Review of Raw material, In-process, Intermediate and Finished product specifications.
  • Performing Internal Audit and Unannounced laboratory inspection to ensure the procedural compliance.
  • Ensuring CSVC/IT compliance
  • Handling of CAPA activities.
  • Review of Instrument qualification documents.
  • Review of Calibration planner/reports.
  • Review of Analytical method validation and method transfer protocols and reports.
  • Review of Laboratory standard qualification reports.
  • Review of stability summary reports.
  • Review of APQR (Annual Product Quality Review)
  • Review of Audit trail related to analytical testing.
  • Supports to Regulatory Affairs Team by providing the documents for DMF filing and to respond regulatory and customer queries.
  • Actively participates regulatory and customer Audits.

If you are interested in our company, kindly share us your updated profile, Mail Id: ch-admin@natcopharma.co.in

 

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