Pfizer Senior QA Specialist (PC1) in Tuas, Singapore
PC1 is part of Hospital BU and responsible for managing the product flow and sales order management from the PGS sites to the end customer.
Lead assigned PC1 Quality representative. Responsible and accountable for quality issues, concerns and communications as it relates to the PC1 Quality Agreement with the PC1 customer.
Point of Contact for PC1 Customer, PC1 Account lead and PC1 LT. This would include notifications for: investigations, change requests and regulatory audits
Point of contact and owner of quality agreement
Subject Matter Expert on PGS site quality systems. Including the ability to present the PGS site quality systems during manufacturing, development activities and routine PC1 Operation meetings
Manage the review and evaluation of sensitive and confidential information
Participates in PC1 customer plant audits, responsible for drafting responses to cover all Quality System findings and managing customer actions and communicating to customer audit updates
Reviews documents for accuracy and ensure they meet quality documentation requirements for both Pfizer and the PC1 Customer. After the review, individual is the final Quality approver for the documentation. The documentation includes: Exception reports, batch records, SOP's, Validation Reports, Technical Transfer Reports and Change Requests
Prepare Quality Technical Agreements (QTAs) and revisions and coordinate changes, review and approvals. Coordinate change control process for QTAs
Quality communication/notification to PC1 customer regarding; exception reports, audits, APRR, change control. Address follow up questions/clarification from customers.
Understand manufacturing process specific to assigned customers. Populate, report out and react to quality metrics for individual PC1 customers. Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.
Participate in all meetings, site visits and audits specific to the assigned PC1 customers. Capture defined actions and track to completion. Act as the liaison between PC1 Customer and Plant Quality functions (Laboratories, Compliance, etc).
Degree in Chemistry, Microbiology, Engineering or other Science related discipline; MBA or graduate degree an advantage
10+ years of experience in pharmaceutical manufacturing or quality, compliance or regularity background experience is an advantage
Specific subject matter expert (SME) in Manufacturing, Quality Systems or Regulatory/Compliance processes
Demonstrated ability to manage multiple projects
Ability to collaborate with the PC1 customer to understand their expectations while supporting the plant quality systems and processes
Effectively communicate through written and oral means
Firm understanding of the concepts incorporated in Quality Assurance in a GMP environment
Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision.
Experience working in a cross-functional, matrix environment
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