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Senior Officer, Qa (Bec)-Arpl-Bca Ar

2-4 years
Not Disclosed
10 Sept. 23, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.