Senior Project Leader QA Validation Oversight
Location:
Posted:
November 09, 2016
Reference:
WD94940
Basic qualifications:
• 5 years of experience in any of the following: Process, Equipment, Computer,
Utilities, Cleaning Validation and Change Controls.
• Knowledge of cGMPs, FDA and other Regulatory requirements.

Bachelor's Degree, preferably in Physical Science or Engineering

Preferred qualifications:
Prior Experience with:
- process validation
- auditing documentation for compliance
- participation on EI teams

Details:
Provide quality oversight for process, equipment, utilities and cleaning validation projects. Review and approve validation protocols. Manage change controls.•

Review and approve all Process, Equipment, Cleaning and Utilities Validation Protocols for compliance to internal
Process Validation Program requirements.
• Review and approve all Process, Equipment, Cleaning and Utilities Engineering Validation Quality/Deviation
Assessments for impact to the state of Process Validation.
• Participate on EI Teams as required to provide QA Validation Impact Assessments and Compliance guidance.
• Review and approve all Critical Documents, Critical Change Control Requests/Assessments for impact to the state of
Process, Equipment, Cleaning and Utilities Validation, as well as site compliance.
• Periodically audit all Process, Equipment, Cleaning and Utilities Engineering Validation documentation for compliance
to all internal/external Regulatory Policies and Guidelines (cGMP's, SOP's, NDA's, GQP/G's, Technical Dossiers,
TTS's, etc.).
• Prepare and report all Process, Equipment, Cleaning and Utilities Engineering Validation audits through PPR's,
Validation Periodic Reviews, etc.
• Participate in teams to present Product QA and Process, Equipment, Cleaning and Utilities Engineering Validation
documentation during Internal and External Regulatory inspections and prepare responses to deficiency reports.
• Review and coordinate Change Controls.

Contact information:

You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

Know someone who would be interested in this job? Share it with your network.