Associate, Production Iii-bpo-pro B

5 days ago

Brantford, Canada Apotex Inc. Full time

**About Apotex Inc.**

**Job Summary**:
The Associate, Production is responsible for the detailed review and verification of all in-house production documents to ensure completeness and accuracy, incuding batch and cleaning records and related items.

**Responsibilities**:

- Review executed process/production documentation (batch records (WBR), cleaning records (CR), and related forms and logbooks (inventory work sheets, raw material picklists, ECVRs, in-process test results, temperature and pressure charts) against current Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP) to ensure that records are complete
- Review Cleanign Records and Batch Records in a timely manner, and in support of the release and shipping schedule
- Assist Plant Operators in the completion of their documents
- Collaborate with Plant Operators to coach them on good documentation practices to drive continuous compliance improvements
- Report any documentation errors and deviations to the supervisor
- Collaborate with QA Auditors to reconcile deviations and documentation discrepancies
- Maintain and update relevant databases such as: emissions, equipment cleaning, SAP phase times
- Complete periodic SOP review; SOP (TBR) monitoring; official copy control
- Ensure that safety procedures are complementary to operational SOPs/instructions; report any discrepancies to your supervisor
- Production and Process logbook issuance/archiving/control
- 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.

**Job Requirements**:

- Education
- High school diploma
- College diploma or University degree in Pharmaceutical Technology, Chemistry, Engineering (or related science) is an asset
- 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 the understanding of significant figures and calculations
- Working knowledge with MS Office, especially Word and Excel
- Knowledge of industry Good Manufacturing Principles (GMP) and Good Docuemntation Prinicples (GDP) requirements is an asset
- Time management, planning, prioritization, attention to detail and analytical/problem solving skills are an asset
- Experience
- Experience working in an API environment
- 1 year experience in a support or administrative position

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.

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