Associate, Mts-cleaning Validation

2 weeks ago

Etobicoke, Canada Apotex Inc. Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
Responsible for planning and executing cleaning validation activities in accordance with FDA, HPFBI, EMA, and ICH’s guidelines and applicable Apotex policies and processes.

**Responsibilities**:

- Liaises with key business members to generate CV Product and SOD Risk Assessment reports, when evaluating new and/or changes to product formulations and equipment cleaning procedures to assess if Cleaning Validation Protocol studies are required.
- Generates Cleaning Validation protocols/studies. In developing these studies, sampling requirements and acceptance criteria are selected to represent worst-case conditions and the sampling and testing criteria are designed for world-wide regulatory compliance (FDA, HPFBI, EC and ICH standards).
- Co-ordinates the cleaning validation event activities (sampling, cleaning, testing requests) with the assistance of production/packaging as required.
- Executes cleaning validation/verification events:

- LIMS project generation and sampling preparation,
- Perform visual inspection and sampling of equipment,
- Delivers samples to the laboratory,
- Perform Viewing of cleaning execution, and
- Complete LIMS and/or visual inspection form result entry and electronic filing of completed results.
- Reviews lab results for compliance to validation protocol acceptance criteria, updates the appropriate tracking and filing systems, and communicates results for equipment release.
- As necessary, evaluates, maintains and orders sampling supplies.
- Provides coaching to technicians and operators involved in cleaning validation activities.
- Provides technical assistance, in conjunction with the management team, related to validation to outside suppliers and various departments and divisions within Apotex. May sit on necessary project teams as required.
- Communicates project status updates to management through the use of tracking sheets (Excel or MS Project).
- Performs other related duties as assigned.

**Job Requirements**:

- Education
- Bachelor’s degree in Science or Engineering
- Knowledge, Skills and Abilities
- Proven organizational, risk management, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast paced environment.
- Excellent English oral and written communication skills are a must. Strong technical writing skills are required.
- High level of familiarity with Microsoft Office (Excel, Word) is required. LIMS experience is an asset.
- Must be able to excel both within a team environment and independently.
- Experience
- Previous experience in the pharmaceutical or other related industry is preferred.

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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