Pfizer Senior Executive -Quality Assurance
Minimum Experience required ; 8 Years
1. In Formulation facility (3-5 years’ experience in
injectable facility)
2. Quality Auditor Certification program or ISO Lead Auditor
Certification or equivalent preferred
Apply knowledge of applicable regulations and guidelines (FDA
21CFRs, ICH, EU, ISO, cGMP) to assure adherence to company, industry, and
governmental standards.
Create annual audit summary reports and perform risk
assessment activities for preparation of the following year audit schedule
Generate audit schedule, plan audit, write report,
communicate audit findings to auditee and management,
Conduct opening and closing meeting for quality system based
audits. Lead audit team as required.
Responsible for review, approval and implementation and
verification of Corrective Action and Preventive Action.
Conduct walkthrough audits and quality system based audits.
Trend and generate audit findings and departmental metrics
To participate in external Vendor Audits/Contract testing
Laboratories/GMP service providers
Perform gap assessments for network regulatory observations
and implement CAPAs
Support site inspection readiness plan and track the action
items for timely closure.
To ensure for the cGMP compliance of all Standard operating
Procedures/ Quality Management system
Engage to continuous knowledge development regarding rules,
regulations, best practices, and performance standards in pharmaceutical
industry.
Pfizer is an equal opportunity employer and complies with all
applicable equal employment opportunity legislation in each jurisdiction in
which it operates.
Quality Assurance and Control
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