Job Description

Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contributions have a direct impact on patients. This commitment to quality and safety ensures that our products meet the highest standards, making a real difference in the lives of those who need them. Your role is crucial in maintaining this standard, and together, we strive to innovate and improve, ensuring that our patients receive the best possible care.
What You Will Achieve
In this role, you will:

• Drive the investigations for Quality robustness within the timelines.
• Review of investigation for root cause analysis and appropriate corrective actions implemented.
• Compliance to site investigations procedures.
• Facilitate investigations and implement corrective actions, ensuring timely closeout.
• Undertake and implement improvement plans to meet the Quality department's goals and Key Performance Index (KPI).
• Liaise and influence the cross functional team to drive the site investigations to meet the supply reliability.
• Monitor, review, develop and implement the action plan for investigation program & metrics sustenance.
• Derive appropriate training methodologies to improve and maintain the capability and competency of investigators and approvers.
• Undertake and implement improvement plans to meet the Quality department's goals.
• Evaluate data and trends, report results to management.

Here Is What You Need (Minimum Requirements)

• Preferably 8-10 years of experience in Quality Assurance /Quality Control function of Sterile manufacturing facility.
• Solid background in people management
• Expertise in handling investigations through a Quality Tracking system
• Well-versed in GMP Manufacturing as well as QA/QC Laboratory environments
• Project management experience
• Strong interpersonal and influential skills to effectively lead and collaborate with teams
• Ability to analyze information using various statistical tools
• Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team.

Bonus Points If You Have (Preferred Requirements)

• Master's degree coupled with relevant pharmaceutical experience
• Comprehensive expertise and familiarity with all facets of biologic manufacturing, including cell culture, fermentation, purification, microbiology, and chemistry
• Robust understanding of DMAIC methodology and Method 1 coaching training, or similar
• Experience in developing team capability and skills through continuous support and one-on-one coaching
• Ability to review, develop, and introduce systems, practices, and cultural changes
• Strong organizational and time management skills

Work Location Assignment: On Premise
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

Skills Required