Senior QA Specialist (PC1)

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

• 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).

BASIC QUALIFICATIONS

• 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

PREFERRED QUALIFICATIONS:

• 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

  
Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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