Manufacturing Specialist

6 days ago


Brantford, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a global pharmaceutical company that specializes in the development and production of high-quality medicines. With a strong presence in over 75 countries, Apotex employs a team of professionals in various fields, including manufacturing, research and development, and commercial operations.

Job Summary

The Production Associate, PO5, plays a crucial role in ensuring the accuracy and completeness of production documents. This position requires a detail-oriented individual who can review and verify documents against current Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP).

Key Responsibilities

  • Review and verify production documentation, including batch records, cleaning records, and related forms and logbooks, to ensure compliance with GMP and SOP.
  • Collaborate with Chemical Operators to coach them on good documentation practices and drive continuous compliance improvements.
  • Report any documentation errors or deviations, including those discovered during documentation review.
  • Initiate and investigate deviations, track deviation trends, and provide suggestions to improve overall productivity and increase compliance.
  • Work closely with Technology Operations and Engineering to simplify and standardize execution instructions and production equipment.
  • Collaborate with QA Auditors to reconcile deviations and documentation discrepancies.
  • Maintain and update relevant databases, including emissions, equipment cleaning, and SAP phase times.
  • Complete periodic SOP review, SOP monitoring, and official copy control.
  • Ensure safety procedures are complementary to operational SOPs/instructions and report any discrepancies to the supervisor.
  • Production and Process logbook issuance/archiving/control.
  • Work in a safe manner, collaborating as a team member to achieve all outcomes.
  • Demonstrate behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

Requirements

  • Education: High school diploma, College diploma, or University degree in Pharmaceutical Technology, Chemistry, Engineering, or related science.
  • Knowledge, Skills, and Abilities: Good command of the English language, both written and verbal; demonstrated ability to communicate in a clear and effective manner; able to follow instructions according to written procedures; proficient math skills and understanding of significant figures and calculations; working knowledge of MS Office, especially Word and Excel; knowledge of industry GMP and GDP requirements is an asset.
  • Experience: Minimum 2 years' experience working in an API environment; experience in investigations is strongly preferred.


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