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Job Description

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.


What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products/incoming materials to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.


Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.


As a Team lead, you will be involved in leading work teams within your division, including the technical and financial resources of the team. Thanks to your technical skills, you will coach your direct reports on day to day activities. You will be relied on to solve complex problems within your area of expertise.


It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.


How You Will Achieve It
  • Manage multiple projects and ongoing work activities of within a work team and ensure agreed upon timelines are met.
  • Oversee and 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.
  • Serve as a point of contact for issues related to laboratory applications and core solutions.
  • Engage with business partner to identify areas of improvement across laboratory and core applications and processes.
  • Provide technical expertise and support to the QC laboratory for laboratory and core applications.
  • Manage review and approval of Good Manufacturing Practices {also cGMP} documentation, such as procedures, data and reports.
  • Running the 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.
  • Running Incoming materials section. Responsible for developing section colleagues and prepare a succession plan for Incoming materials section.
  • Act as site SME for Stability and microbiology.
QualificationsMust-Have
  • Bachelor's Degree
  • 5+ years’ experience
  • Laboratory supervisory experience in FG, Stability, Microbiology &/or Incoming materials.
  • Knowledge of Good Manufacturing Practices {also cGMP}/SFDA compliance requirements for Quality Control Laboratories
  • Experience with leading colleagues and/or projects
  • Strong people management experience
  • Demonstrated skills in collaboration, attention to detail, and communication skills
  • Ability to handle complex and detailed situations with a focus on quality
Nice-to-Have
  • Master's degree
  • Relevant pharmaceutical experience.
  • Experience with microbiological risk assessments
  • Knowledge of Laboratory Information Management System Empower, Microsoft Office and DI concepts.
  • Working knowledge and understanding of requirements as it relates to method qualification and testing of components and finished products
  • Six Sigma (Green belt) certified.
  • Quality certificate is a plus.

PHYSICAL/MENTAL REQUIREMENTS


• Good command of English both written and spoken.


• Knowledgeable with interpersonal learning.


• Communication, teaching and coaching skills.


• Logic way of thinking


• Management and decision making skills


• High analytical skills


• Professional in reports writing.


• PC literate with the following applications: MS Excel, Word, PowerPoint


  
Work Location Assignment: On Premise


#LI-PFE


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
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