Senior Quality Assurance Manager, Pharmaceutical Development

7 days ago


Bengaluru, Karnataka, India Apotex Full time

At Apotex, we are committed to fostering a culture of excellence in quality assurance.

About Apotex

Apotex is a Canadian-based global health company dedicated to producing high-quality medicines for patients worldwide. With a workforce of nearly 7,200 employees globally, we operate manufacturing, R&D, and commercial operations.

Job Overview

We are seeking an experienced Senior Quality Assurance Manager to lead our Analytical Research Development Laboratory (ARD) team. This role requires strong leadership and technical expertise in pharmaceutical quality assurance.

This position oversees the review of analytical data and documents, as well as the management of laboratory activities. The successful candidate will ensure the quality oversight of drug product analytical method development, validation, and verification activities, adhering to global standards.

Key Responsibilities
  • Review and approval of analytical method validation, method verification, and development protocols and reports
  • Management of team members and establishment of day-to-day operational procedures for smooth product development
  • Review of compendial method verification protocols and reports
  • Support to the Development Quality Assurance team for analytical method development and validation activities
  • Review and approval of laboratory change controls, deviations, corrective/preventive actions, and laboratory investigation reports
Requirements
  • M Pharma/B Pharma degree with 10-12 years of experience in pharmaceutical quality assurance
  • Extensive knowledge of GMP and GLP requirements, specifically 21 CFR 210 and 21 CFR 211
  • Experience with oral dosage formulations and prior exposure to R&D quality systems and documentation procedures
  • Team management and prioritization skills, effective planning of work activities to meet timelines
Benefits and Compensation

Competitive salary: $120,000 - $160,000 per annum

Benefits package includes medical, dental, and vision coverage, as well as opportunities for professional growth and development



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