Bachelor’s/Master’s Degree in a scientific discipline with 2-5 years working experience in the Biotech/Pharmaceutical industry.
Should have Knowledge of change management, CAPA Management and Quality risk Management.
change control initiation for implementing Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations
Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
Review, edit, and revise controlled documentation in accordance with cGMP standards
Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls.
Qualifications
Must-Have
Bachelor’s/Master’s Degree
Demonstrated working knowledge and understanding of sterile Manufacturing procedures.
Knowledge of Good Manufacturing Practices {also cGMP}, validation principles, audit techniques, and working knowledge of change management.
Effective communication skills, both verbal and written.
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
#LI-PFE
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