Job Title:
Executive – Quality Assurance (ARPL-AQAR AR)
Date Posted: August 11, 2025
Location: Bangalore, Karnataka, India, 560099
Company: Apotex / ApoPharma
Company Overview:
ApoPharma, a member of the Apotex Group of Companies, is a pharmaceutical company dedicated to the discovery, development, and delivery of novel medicines that improve the quality of life for patients suffering from debilitating and life-threatening diseases. A major research focus is the role of iron in human disease and the development of therapies targeting iron-related conditions.
Position Summary:
The Executive – Quality Assurance will be responsible for the review and verification of analytical documentation across various laboratory functions to ensure regulatory compliance and data integrity in line with GMP and company SOPs. This role also supports regulatory inspections, training, and overall quality system implementation.
Key Responsibilities:
1. Documentation & Data Review
Review analytical documents, including:
Commercial stability reports
In-process (IP), Semi-finished goods (SFG), Raw materials (RM), and Packaging materials (PM) data
Review qualification and calibration reports for lab instruments.
Review working standard reports and analytical records generated by laboratories.
Review and verify analytical data through LIMS (Laboratory Information Management System).
2. Quality & Compliance Oversight
Ensure readiness and support for Health Authority inspections.
Review and manage Deviations, Lab Events, Temporary Changes, CAPAs, Non-CAPA follow-up tasks, and LIRs (Laboratory Investigation Reports).
Ensure compliance with cGMP, cGLP, cGXP, and company quality systems.
3. Training & Documentation Control
Complete required training before executing any activity.
Submit and manage documents for archival and documentation updates per SOPs.
Provide and conduct training related to procedure review and updates.
4. General Responsibilities
Ensure safe working practices in accordance with organizational guidelines.
Demonstrate and promote core organizational values:
Collaboration, Courage, Perseverance, Passion
Comply with all corporate programs and policies:
Global Business Ethics and Compliance
Global Quality Policies and Procedures
Safety and Environmental Policies
Human Resources Policies
Perform other duties as assigned.
Qualifications:
Education:
Minimum: Bachelor’s degree in Pharmacy, Science, or equivalent
Experience:
Minimum 2 years of experience in a GMP-regulated pharmaceutical industry
Skills & Competencies:
Strong knowledge of pharma industry practices and regulatory updates
Attention to detail and vigilance in daily activities
Good organizational and management skills
Proficiency with LIMS and documentation systems preferred
Equal Opportunity & Accessibility:
ApoPharma is committed to fostering a diverse, inclusive, and accessible workplace. Accommodations are available upon request during the recruitment process for candidates with disabilities. If contacted for an interview or testing, please inform the team of any accommodation requirements.
About Apotex:
Apotex is a global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Through its subsidiaries like ApoPharma, the company is involved in both generic and innovative drug development.
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