Engineering Validation Specialist
GSK
Mississauga, ON
Site Name: Canada - Ontario - Mississauga
Posted Date: Oct 1 2019
** Please note - this is a 12 month contract opportunity **

Job Purpose:
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.

Key Responsibilities:
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

Requirements:
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 canada-recruitment@gsk.com

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.