Senior Documentation Officer

Senior Officer - Documentation

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

Job Summary

A role holder to Prepare batch documents (MMaRs and MPaRs) for new launch, site transfer, Commercial batch documents and batch records for trials. Initiation of QMS activities and timely closure in compliance with regulatory standards and procedures.

Job Responsibilities

• Initiate Master Manufacturing Records (MMaRs) & Master Packaging Record (MPaRs)
• Initiate Placebo and Optimization batch record for trails.
• Initiate Change Controls in QMS Track Wise for New Launch / Site Transfer / Submission batch / SOPs / Formats and commercial batch documents.
• Ensure QMS Change control closure within the stipulated timeline.
• Ensure support for timely completion of Investigations for document related deviations and document revision based on CAPA.
• Initiation of batch documents , SOPs and Formats in Content server.
• Check Monthly Schedule to ensure document readiness.
• Ensure all changes are aligned with cGMP regulations and corporate SODs.
• Perform all work in accordance with established regulatory, compliance and safety requirements.
• Coordinate with NPL and RA regarding Deficencies from Regulatory Agencies and Clarifix.
• Develop and maintain effective working relationships with internal and external customers.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies and HR policies.
• All other relevant duties as assigned.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education
  • Minimum Bachelor of Pharmacy / Science or any equivalent degree.
• Experience
  • Minimum 1 year of experience in GMP regulated pharmaceutical industry.
•  Knowledge, Skills and Abilities
  • Adequate knowledge in handling QMS Trackwise tool, Content server tool.
  • People management skillset
  • Adherence to cGMP
  • Exhibit Perseverance in all the tasks performed
  • Problem solving skills

Exigences liées au poste

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

Experience Level

Senior Level