QA Inspector - Validation

POSITION SUMMARY:

The QA Inspector is responsible for performing Commissioning, Qualification & Validation activities such as project documentation review, execution of equipment acceptance testing, and documentation turnover package assembly for custom process equipment primarily for pharmaceutical and biopharmaceutical applications.

DUTIES AND RESPONSIBILITIES:

· Prepare equipment acceptance test protocols based on Turnkey Modular Systems testing standards and client requirements.

· Lead the execution of Factory Acceptance Testing (FAT) and / or Site Acceptance Testing (SAT) on finished process systems, including but not limited to the following tasks:

o Process walk-downs to verify that the system is fabricated as per the engineering detailed design documents;

o Component verification;

o Piping Slope verification;

o Instrument and valve functionality tests;

o Electrical and control system checks; and

o Equipment documentation review.

· Work with validation team to review welding documentation, vessel documentation, component certification, and engineering documentation.

· Assemble physical documentation binders and electronic turnover package based on vendor documentation requirements.

· Assist receiving inspectors in performing inspection and documentation activities.

· Maintain action lists / punch lists.

QUALIFICATIONS:

· Post-Secondary education in Science or Engineering preferred.

· Minimum 2-year relevant work experience which demonstrates knowledge of validation principles, including: validation planning, user requirement and functional specifications, commissioning, IQ, OQ, PQ for pharma and biotechnology industries.

· Thorough understanding of good documentation practices (GDP) and good manufacturing practices (GMP).

· Knowledge of biopharmaceutical/nuclear industry standards and guidelines.

· Detail oriented and strong organizational skills.

· Possess initiative and ability to interact with a variety disciplines and production teams.

· Effective problem solving, root cause analytical skills.

· Strong written and verbal communication skills.

· Strong computer skills with experience using MS Office and Adobe PDF editor.

· Must be mobile within the GTA.

· Flexibility and willingness to travel to the site if needed. Office and Adobe PDF editor

Job Type: Full-time

Pay: $28.00-$32.00 per hour

Expected hours: 40 per week

Benefits:

- Casual dress

- Company events

- Dental care

- Disability insurance

- Employee assistance program

- Extended health care

- Life insurance

- On-site parking

- Paid time off

- RRSP match

- Vision care

Ability to commute/relocate:

- Oakville, ON L6J 7R2: reliably commute or plan to relocate before starting work (required)

Experience:

- Validation: 2 years (preferred)

- QA/QC: 2 years (preferred)

Work Location: In person

Application deadline: 2025-08-28

Expected start date: 2025-09-02