Senior Officer, QA (BEC) – ARPL-BCA AR
Company: Apotex
Location: Bangalore, KA, IN, 560099
Date Posted: September 21, 2025
Website: www.apotex.com
About Apotex
Apotex is a Canadian-based global health company focused on improving everyday access to affordable and innovative medicines and health products worldwide.
Portfolio: Generic, biosimilar, innovative branded pharmaceuticals, and consumer health products
Headquarters: Toronto, Canada
Global Presence: United States, Mexico, India, and more
Specialty: Largest Canadian-based pharmaceutical company and a key partner for pharmaceutical licensing and product acquisitions in the Americas
Job Summary
The Senior Officer, QA is responsible for monitoring, auditing, and assuring the quality of operational aspects within the facility. Work is conducted according to Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), best practices, and regulatory requirements, with support from auditors and senior members.
Key Responsibilities
Compliance & Auditing
Ensure assigned work complies with GCP, GLP, SOPs, regulatory requirements, best practices, and safety standards.
Perform audits (project and non-project related) in:
Bioanalytical Operations
Clinical Operations
Pharmacokinetic Unit
Quality Assurance Unit
Other divisional operations as applicable
Conduct in-process surveillance to assure ongoing compliance in the relevant departments.
Prepare QA audit reports for all audits/surveillances performed.
Follow up on audit findings and ensure completion of unresolved issues.
Documentation & Systems
Review audit/software validation packages and IQ/OQ documents for facility systems.
Revise, implement, and maintain SOPs and other relevant documentation.
Assist in internal audits as required.
Training & Reporting
Assist in formal training of new and existing QA staff on QA procedures and facility audits.
Report operational status and audit outcomes to QA Management.
Compliance & Safety
Ensure all work follows regulatory, compliance, and safety requirements.
Collaborate with team members to achieve organizational outcomes safely.
Exhibit organizational values: Collaboration, Courage, Perseverance, Passion.
Adhere to Global Business Ethics and Compliance Program, global quality policies, safety/environment policies, and HR policies.
Other Duties
Perform additional duties as assigned by QA Management.
Job Requirements
Education
Minimum: Bachelor’s degree in Science or Pharmacy
Skills & Knowledge
Knowledge of ICH guidelines, GCP, GLP for BA/BE studies
Technical skills in LIMS, EP, and Analyst software
Ability to perform audits according to GDP, GLP, GCP, and other regulatory requirements
Experience
2–4 years in a regulated industry
Diversity & Inclusion
Apotex is committed to a welcoming and accessible work environment. Applicants requiring accommodation during the recruitment process are encouraged to notify the company.
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