Manager / Section Head IPQA

2 days ago

Khalapur Panvel Raigad, India V Ensure Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Dear Candidates,

We are looking for our USFDA & EUGMP approved plant located at Rasayani, Patalangana MIDC for Manager / Section Head IPQA.

Role & responsibilities

  1. To Lead IPQA activities.

  2. Strategies, plan and organize the team's resources to perform day to day operations

  3. Ensure Quality compliance as per CGMP requirement in manufacturing facility and inspection readiness at all times and represent in regulatory audits.

  4. Review and approval of all SOPs, protocols, reports related to IPQA section.

  5. To provide Line clearance by ensuring clearance of documents as per requirement.

  6. To verify and coordinate In process and finished product, cleaning validation and any other sampling.

  7. Investigation of critical deviations, Incidents, OOS, OOTs, market complaints, recalls and any other related to the manufacturing facility.

  8. Ensure acceptance quality level and certification of inspectors as per respective SOP.

  9. Initiation, review and approval of QMS documents (Change control, Deviation, CAPA but not limited to).

  10. To prepare and review Quality Risk Assessment.

  11. Evaluation and Approval of Qualification documents (Area/ facility/ equipment), Risk assessment, protocols, reports and Annual product review.

  12. Monitoring execution of calibrations of IPQA equipment / instrument as per calibration schedule with respective SOPs.

Preferred candidate profile

Candidate must have experience in Pharma Formulation Company and exposure in Regulated Market(USFDA & EU - GMP).

Team handling experience is mandatory.

Interested candidates can share Cv on : -

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