Engineering Validation Specialist
Site Name: Canada - Ontario - Mississauga
Posted Date: Oct 1 2019
Please note - this is a 12 month contract opportunity
The job purpose is to provide validation oversight (review and approval) for activities associated with facility systems. To provide validation expertise for facility systems including as required the writing, executing and summaries for facility systems. Additionally, the collation and summaries of Equipment Validation Review reports will be required.
- Conduct validation reviews and prepare review reports for equipment and facility systems
- Develop and/or update validation master plans
- Prepare, review, approve and execute Qualification Protocols and generate summary reports for facility systems.
- Assess planned changes for validation impact on facility.
- Acting as SME Engineering Validation, , support site RCA and investigations as required providing impact to Validation status.
- Perform department internal self inspections and ensure compliance with internal and Regulatory standards
- Review and evaluate QMS documents pertaining to the area of responsibility and write gap analysis and update procedures accordingly
- Respond to queries from Regulatory authorities, third party auditors and internal auditors and participate in inspections as required (mission control, subject matter expert)
- Provide validation risk assessments for changes as appropriate
- Bachelors Degree in Science or related field preferred, or equivalent on the job experience through years of service.
- Knowledge of GMP, Quality Control, Quality Assurance, Production or Engineering
- Good understanding of the principles of validation
- Minimum 2 years in Pharma industry
- Demonstrated ability to make informed decisions on validation requirements and approach
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at firstname.lastname@example.org
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