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St-coordinator, Mts-cleaning Validation

2 weeks ago

North York, Canada Apotex Inc. Full time

**About Apotex Inc.**

**Job Summary**:
Responsible for assisting in the planning, execution and tracking of cleaning validation activities in accordance with FDA, HPFBI, EU, and ICH guidelines and applicable Apotex policies and processes.

**Responsibilities**:

- Co-ordinates the cleaning validation activities (sampling, cleaning, testing requests) with the assistance of production/packaging as required.
- Assists cleaning validation personnel during sampling of manufacturing equipment for product drug active, detergent and microbial residues.
- Communicates analytical testing priority to the lab for all swab sampling.
- Provides troubleshooting assistance for remedial and corrective actions in the case of unacceptable validation results.
- May assist in the review and assessment, in conjunction with the Project Leader/Supervisor, of proposed changes to production equipment and cleaning procedures on the validation program using the appropriate change control procedures.
- Extract and consolidate data from laboratory, production and packaging documents.
- Help to organize, manage and update cleaning validation tracking database.
- Participate in the monitoring program including viewing of the cleaning validation activities and completion of protocol checklists.
- 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
- Post-secondary Science, Engineering or related discipline.
- Knowledge, Skills and Abilities
- Working knowledge of Word, Excel and Power Point are essential.
- Strong oral and written communication skills.
- Experience
- Currently enrolled in a post-secondary education program

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.