Senior Officer - Documentation
Company: Apotex
Location: Bangalore, Karnataka, India
Job Type: Full-Time
About Apotex
Apotex is a Canadian-based global health company committed to improving access to affordable, innovative medicines and health products worldwide. With a broad portfolio of generic, biosimilar, branded pharmaceuticals, and consumer health products, Apotex serves millions of patients across global markets.
Position Summary
The Senior Officer - Documentation will be responsible for preparing and managing manufacturing and packaging batch documentation for new product launches, site transfers, commercial production, and trial batches. The role also involves initiating and managing Quality Management System (QMS) activities, ensuring timely closure of change controls, and maintaining compliance with cGMP and regulatory requirements.
Key Responsibilities
Documentation Management
Prepare and initiate Master Manufacturing Records (MMaRs) and Master Packaging Records (MPaRs).
Prepare placebo and optimization batch records for trial batches.
Initiate batch documents, SOPs, and formats within the Content Server.
Review monthly production schedules and ensure document readiness.
Support document revisions and updates based on CAPA requirements.
Quality Management System (QMS)
Initiate Change Controls in QMS TrackWise for:
New product launches
Site transfers
Submission batches
Commercial batch documents
SOPs and formats
Ensure timely closure of QMS Change Controls within established timelines.
Support investigations related to documentation deviations and ensure timely resolution.
Compliance and Regulatory Support
Ensure all documentation activities comply with cGMP regulations and corporate SOPs.
Coordinate with New Product Launch (NPL) and Regulatory Affairs teams regarding regulatory deficiencies and clarification requests.
Maintain compliance with regulatory, quality, safety, and company standards.
Support audit readiness and regulatory inspection requirements.
Collaboration and Communication
Develop and maintain effective working relationships with internal and external stakeholders.
Collaborate with cross-functional teams to ensure smooth documentation processes.
Support continuous improvement initiatives within the documentation function.
Additional Responsibilities
Perform assigned duties in accordance with company policies and compliance programs.
Demonstrate Apotex core values: Collaboration, Courage, Perseverance, and Passion.
Adhere to Global Business Ethics, Quality, Safety, Environmental, and HR policies.
Qualifications
Education
Bachelor's Degree in Pharmacy, Science, or an equivalent qualification.
Experience
Minimum 1 year of experience in a GMP-regulated pharmaceutical industry.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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