Job Description
AUDIT AND INSPECTION
•Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, BUs, and Platform Line representatives as applicable.
•Develop and maintain the in-country Regulatory Inspection Site Notification Plan.
•Communicate relevant Inspection announcements as per applicable Regulatory Inspection Site Notification Plans.
•Coordinate RQA PCO audits, and provide support for audit systems.
•Provide consultancy recommendations for audit-related Corrective & Preventive Actions (CAPAs) as applicable.
•Support Corporate Audit requests within scope of GMQG as appropriate.
SOPs, PROCEDURES AND TRAINING OVERSIGHT
•Support the process of impact assessment of new or revised regulatory requirements and legislation impacting the local clinical and medical controlled documents (CMCDs) local references.
•Develop or support the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04 and within MQGM remit in collaboration with relevant Subject Matter Experts.
•Act as local expert on QMS04 and ensure that local CMCDs within MQGM remit follow applicable Pfizer policies and procedures and regulatory requirements.
•Provide input to draft Global /SOPs /Policies/Working Instructions and related training materials offering the country perspective and local impact
TRAINING
• Ensure local training requirements in MQGM remit are included in the appropriate curricula.
• Ensure local curricula in MQGM remit are maintained in line with Pfizer standards.
• Facilitate local training compliance reporting for in-country Medical Affairs where needed.
• Act as a medical expert on QMS07 and Pfizer’s Global Learning Management System.
• In collaboration with local management, identify additional local training needs on quality related areas; facilitate/ support/ conduct of additional training for identified areas if applicable.
