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