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Pfizer

Quality Control Supervisor

Posted 2 Days Ago
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Hybrid
Plant, TN
Senior level
Hybrid
Plant, TN
Senior level
Oversee Quality Control operations, ensure compliance with cGMP, lead projects, and manage teams within QC laboratory environments.
The summary above was generated by AI
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. You will play a crucial role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership will be instrumental in driving innovation and excellence, ultimately making a global impact on patient health.
What You Will Achieve
In this role, you will:
  • Lead people, technology, and financial resources in QC finished products and Microbiology sections.
  • Identify and develop innovative concepts for process or product improvements, taking calculated risks to achieve results.
  • Solve complex problems, leveraging experience from various areas as needed.
  • Recognize and address development needs, creating growth opportunities for colleagues.
  • Lead , oversee and/or manage multiple projects and ongoing work activities, ensuring compliance with approved methodologies and cGMP documentation.
  • Provide technical expertise and support for laboratory and core applications, collaborating with business partners to identify and implement improvement areas.
  • Utilize IMEx methodology and tool "Lean &sigma" to lead continuous improvement activities in QC laboratory
  • Conduct , oversee and/or review/approve investigations, CAPA (Corrective Action and Preventive Action) and change controls.
  • Review laboratory data to ensure compliance with approved methodologies.
    Build capabilities of the Process-Centric Team according to skills needs assessments.
  • Provide technical expertise and support to the QC laboratory for laboratory and core applications.
  • Manage review and approval of Good Manufacturing Practices '' cGMP'' documentation, such as procedures, analysis data and reports.
  • Manage work streams Quality Control Finished Good, Stability, cleaning/process validation, Microbiology and Methodology sections.
  • Responsible for developing Quality control Finished Good, Stability and Methodology sections colleagues and prepare Succession plan for the Finished Good, Stability and Methodology sections.
  • Responsible for QC analyst qualification program
  • Act as site SME for Stability and microbiology.

Here Is What You Need (Minimum Requirements)
  • Bachelor's degree in a relevant scientific discipline with 5+ years' experience
  • Laboratory supervisory experience in FP, Stability and/ or Microbiology
  • Proven experience in leading colleagues and managing projects
  • A deep understanding of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories
  • Proficiency with Quality Control instruments and methodologies Microbiology and/ or Finished products analytical
  • Experience in lean manufacturing and sigma concepts and tools
  • Knowledge of cGMP /Saudi FDA compliance requirements for Quality Control Laboratories
  • Proficiency in Laboratory Information Management Systems like Empower and SAP quality module
  • Solid understanding of method qualification and testing of components and finished products
  • Solid understanding of Data integrity requirements
  • Experience in microbiological risk assessments
  • Strong problem-solving skills and the ability to think outside the box.

Bonus Points If You Have (Preferred Requirements)
  • Master's degree or higher in a relevant scientific discipline
  • Lean six sigma certifications.
  • 2+ years of experience in leading people

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
#LI-PFE

Top Skills

Empower
Laboratory Information Management Systems
Lean &Sigma
Sap Quality Module

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