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\xe2\x80\x99s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products 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

• Lead a team of quality professionals by providing oversight in managing testing and quality control activities associated with final drug substances, and their intermediates, in process and direct materials.
• Keep up to date on the regulations/compliance to provide support and guidance to the team to ensure appropriate quality oversight in quality control operations.
• Ensure all direct reports receive required cGMP, EHS and role related training related training required to work safely and in compliance with regulatory requirements and as defined by their learning plan. Provide coaching and mentoring for professional development of staff.
• Engage and inspire their teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
• Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
• Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach their teams.
• Be accountable for the Good Data Management and Data integrity understanding and performance of their team.
• Write, approve and review working procedures for the laboratory.
• Conduct laboratory investigations and ensure all follow up actions are completed Make decisions based on scientific and logical reasoning on behalf of the laboratory manager when required.
• Supervise QC personnel in troubleshooting laboratory equipment failure and laboratory investigation.
• Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operation.
• Conduct training to increase staff knowledge and understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements, product chemistry and sophisticated laboratory equipment.
• Participate and lead site teams/projects e.g. LIMS, CDS, Safety, continuous improvement, Analytical Method Transfer Exercise.
• Supervise the team of analyst and ensure that testing documents (e.g. laboratory notebooks, test methods) accompany the analyst at the same time when testing activities are performed. Ensure analyst follow the ALCOA principles
• Review product and raw material results. Performs quality review of completed test records and release of raw materials, solvents and packaging materials.
• Work closely with key QA, Production, Engineering and EHS personnel to support them in laboratory testing and troubleshooting when required.
• Help to manage the budget of the laboratory expenses.
• Develop the skills and capabilities of QC Chemists & Laboratory Analysts
• Commitment to work and positive influencer/role model/motivate others for overall operational excellence.
• Stand in for the QC Laboratory Manager in his/her absence.
• Effectively monitor the actions of their team. Ensure an active daily presence in the GMP work area to observe the work activity and practices within their role responsibilities.
• Be available to their direct reports for real time escalations of any concerns or support needs
• Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
• Be a role model to support a positive compliance culture.
• Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.

Qualifications

• Bachelor or Master or Ph.D degree in Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmaceutical Science or Microbiology or a related science.
• Not less than 7 years\xe2\x80\x99 experience working in a chemical laboratory, preferably within the pharmaceutical industry and with experience in managing/supervising small (8-12) groups of laboratory analysts.
• Additional experience in Quality Assurance is highly desirable.
• Proven track record in people management and in supervisory role
• Extensive knowledge of GMP compliance requirements for Quality Control laboratories is a must

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

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Pfizer