Senior Officer – Quality Assurance
Location: Bangalore, Karnataka, India – 560099
Company: Apotex Inc.
Date Posted: February 5, 2026
Employment Type: Full-Time
Industry: Pharmaceuticals | Quality Assurance | Clinical & Bioanalytical Operations
About Apotex Inc.
Apotex is a global, Canadian-based health company committed to improving everyday access to affordable, innovative medicines. With a broad portfolio spanning generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex serves millions worldwide. Headquartered in Toronto, with regional offices in the United States, Mexico, and India, Apotex is the largest Canadian-based pharmaceutical company and a trusted health partner in the Americas for pharmaceutical licensing and product acquisitions.
Learn more: www.apotex.com
Job Summary
The Senior Officer – Quality Assurance will ensure the quality, compliance, and regulatory integrity of operational aspects across Bioanalytical, Clinical, and related facility operations. The role includes auditing, monitoring, and implementing QA best practices, supporting auditors, and working closely with senior QA team members to maintain GCP, GLP, SOP, and regulatory compliance.
Experience Required
2–4 years of experience in a regulated pharmaceutical or life sciences environment
Hands-on experience with Quality Assurance, auditing, and regulatory compliance in BA/BE studies or clinical/bioanalytical operations
Educational Qualification
Bachelor’s degree in Science or Pharmacy (minimum)
Key Responsibilities
Quality Assurance & Auditing
Perform audits and in-process surveillance across Bioanalytical Operations, Clinical Operations, Pharmacokinetics, QA Unit, and other divisional operations
Ensure compliance with GCP, GLP, SOPs, ICH guidelines, and regulatory requirements
Prepare detailed QA audit reports and follow-up on unresolved findings to closure
Operational Oversight
Conduct audits and reviews of software validation packages, IQ/OQ documents, and analytical systems
Assist in internal audits, facility assessments, and adherence to QA procedures
Maintain and update SOPs and relevant QA documentation
Training & Mentorship
Support training of new and existing QA staff on audit procedures and regulatory compliance
Provide guidance to operational teams for continuous quality improvement
Compliance & Ethics
Demonstrate adherence to Global Quality policies, Safety & Environment policies, and Business Ethics
Work collaboratively to ensure safe, compliant, and high-quality operations
Perform other QA-related duties as assigned
Required Skills & Competencies
Strong understanding of ICH guidelines, GCP, GLP, and QA principles for BA/BE studies
Proficiency in LIMS, EP, and analytical software tools
Ability to conduct audits and ensure compliance with GDP, GLP, GCP, and other regulatory standards
Excellent analytical, communication, and documentation skills
Collaborative mindset with attention to detail and process excellence
Core Competencies
Process Excellence & Compliance
Collaboration & Teamwork
Result Orientation & Accountability
Strategic Thinking & Risk Assessment
Regulatory Knowledge & Ethical Standards
Why Join Apotex?
Work in a global, regulated pharmaceutical environment with exposure to clinical, bioanalytical, and QA operations
Gain hands-on experience in auditing, process improvement, and regulatory compliance
Collaborate with experienced QA professionals and contribute to high-quality clinical and operational deliverables
Be part of a company committed to innovation, ethical standards, and employee development
Inclusion & Accessibility:
Apotex provides accommodations for applicants with disabilities during the recruitment process. Candidates requiring support for interviews or assessments are encouraged to inform the recruitment team.
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