Senior Validation/calibration Specialist
North York, ON, Canada
Job Description
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Senior Validation/Calibration Specialist We are seeking an experienced Senior Validation/Calibration Specialist with a B.Sc. or an engineering degree. You must have a minimum of 4-6 years of hands-on experience with equipment qualification and calibration in the pharmaceutical/biopharmaceutical/biotechnology industry, including knowledge of analytical lab instruments like HPLC, GC, GCMS, LCMS, FTIR, UV, Stability chamber, Spectrophotometer, TOC, USP/WFI Water Systems, Autoclaves, Production Equipment. Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, Data Integrity, and Information Security. A good understanding of GMP requirements on equipment qualification and related documentation of noted equipment is required and follows USP <1058> Understand and able to review vendor qualification document packages in line with regulatory requirements. Subject matter expertise in areas such as Quality Management, document management, and Change Management. Knowledge of Risk management performs root cause analysis on trends and addresses deviations via preventive, detective, and corrective measures. While we appreciate all applications received, only those selected for an interview will be contacted. Job Types: Full-time, Permanent Salary: $68,000.00-$79,000.00 per year Benefits:
- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- RRSP match
- Vision care
- Wellness program
- French not required
- 8 hour shift
- Overtime pay
- Do you live in the Toronto Area (GTA)?
- Bachelor\'s Degree (preferred)
- hands on pharmaceutical/biopharmaceutical industry: 5 years (preferred)
- USP/WFI Water Systems: 5 years (preferred)
- HVAC, HEPA, Autoclaves: 5 years (preferred)
- Pharmaceutical Filling Equipment: 5 years (preferred)
- Temperature/Humidity Chambers and Mapping: 5 years (preferred)
- Qualification and Documentation of noted equipment: 5 years (preferred)
- English (required)
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Job Detail
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Job IdJD2144448
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationNorth York, ON, Canada
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EducationNot mentioned