Senior Officer – Quality Assurance
Company: Apotex Inc.
Location: Bangalore, Karnataka, India (560099)
Posting Date: February 5, 2026
Employment Type: Full-Time
About Apotex Inc.
Apotex Inc. is a Canadian-based global pharmaceutical organization committed to expanding access to affordable, high-quality medicines and health products worldwide. With a diversified portfolio spanning generic, biosimilar, innovative branded pharmaceuticals, and consumer healthcare products, Apotex operates across key global markets including North America, Latin America, and India. Headquartered in Toronto, Apotex is the largest Canadian-owned pharmaceutical company and a trusted partner for pharmaceutical licensing and product acquisitions.
Position Overview
The Senior Officer – Quality Assurance will be responsible for monitoring, auditing, and ensuring compliance of operational and quality systems within the facility. This role supports adherence to global regulatory requirements, including GCP, GLP, and applicable international guidelines, while maintaining alignment with internal quality systems and standard operating procedures.
Key Responsibilities
Quality Compliance and Audits
Ensure all assigned activities comply with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), and applicable regulatory requirements
Conduct internal audits and in-process surveillance across Bioanalytical Operations, Clinical Operations, Pharmacokinetics, Quality Assurance, and related departments
Perform both project-related and non-project-related audits to ensure ongoing regulatory compliance
Prepare, review, and issue detailed QA audit and surveillance reports
Track audit observations, follow up on corrective and preventive actions (CAPAs), and ensure timely resolution
Systems and Documentation
Review and audit software validation documentation, including IQ/OQ packages for laboratory and clinical systems
Support development, revision, implementation, and maintenance of SOPs and quality documents
Maintain accurate QA records in compliance with regulatory and internal quality requirements
Support internal and external audits as required
Training and Quality Support
Assist in training and onboarding of new and existing QA team members on quality systems, audit procedures, and regulatory expectations
Provide regular updates to QA management regarding audit outcomes, compliance status, and quality-related risks
Collaborate cross-functionally to promote a culture of quality, compliance, and continuous improvement
Compliance and Safety
Ensure adherence to global compliance programs, including business ethics, quality policies, safety, environmental, and HR policies
Demonstrate company values through collaboration, accountability, and professional conduct
Perform additional quality-related responsibilities as assigned
Required Experience and Qualifications
Education:
Bachelor’s degree in Science or Pharmacy (mandatory)
Experience:
2 to 4 years of Quality Assurance experience in a regulated pharmaceutical, CRO, or bioanalytical environment
Key Skills and Knowledge:
Strong understanding of ICH guidelines, GCP, and GLP requirements for BA/BE studies
Hands-on experience with LIMS, electronic protocols (EP), and analytical software systems
Proven ability to conduct audits in compliance with GDP, GLP, GCP, and regulatory standards
Strong documentation, analytical, and communication skills
Ability to work effectively in cross-functional teams within a regulated environment
Why Join Apotex
Apotex offers a supportive and inclusive work environment where quality professionals can enhance their regulatory expertise while contributing to global healthcare access. The organization values integrity, quality excellence, and continuous learning, providing opportunities for professional growth within a global pharmaceutical framework.
Equal Opportunity and Accessibility
Apotex Inc. is committed to fostering a diverse, inclusive, and accessible workplace. Reasonable accommodations are available throughout the recruitment process for applicants with disabilities, ensuring an equitable and supportive candidate experience.
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