Job Description

Why Patients Need YouEverything 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 AchieveYou 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 ItThe incumbent is accountable for the following:

• cGMP, Safety and Quality compliance
• Activities in PGS Reference Standards Program
• Performance and development of direct reports
• Procedure/Report/Data review
• Project implementation and milestones
• Continuous improvement on work processes
• Inspection Readiness

The incumbent will also serve as the Front Line Leader to the team.Responsibilities

• Review data, procedures & records timely and ensure accuracy, completeness and compliance.
• Conduct, write or review investigations in a timely manner. Ensure corrective and preventive actions are appropriate & effective.
• Ensure direct reports are trained, instruments are calibrated/maintained, consumables & methods are available for the certification of reference standards.
• Ensure reference standards are certified, released, available and distributed promptly to customers.
• Ensure a safe working environment for all colleagues. Lead initiatives to promote safety culture & performance and improve engagement.
• Ensure laboratory instruments are qualified to meet regulatory standards, well-maintained and in good working conditions.
• Chair and participate in functional meetings, assigned committee/projects, etc.
• Support Analytical Method Transfer (AMTE) from other Pfizer sites and/or centre functions for new products introduced into the Reference Standards program as required.
• Support regulatory inspections (on site & remote) and/or remediation efforts for Pfizer SLS network laboratories as required.
• Contribute to the budget proposal and management of operating expenses and/or capital expenditure for Reference Standard functional area. Ensure actual expenses are within operational targets.
• Support the forecast and resource planning in Reference Standard functional area.
• Support team and customers in investigation, troubleshooting and impact assessment within area of expertise.
• Lead and/or support continuous improvement initiatives.
• As a Front Line Leader:

• Engage, inspire and coach team on performance expectation.
• Guide and coach team on the processes and procedures, including the ALCOA principles and practices of cGMP.
• Be accountable for the safety and quality compliance understanding and performance of team. Be a role model to support a positive safety and quality compliant culture.
• Ensure an active daily presence in the GMP work area to observe work activity and practices within the responsibilities.
• Be available to direct reports for real time escalation of any concerns or support required.
• Promote positive work culture.
• Be vigilant on potential actions or behaviours that could result in breaches of safety and quality compliance.

QualificationsMust-Have

• Degree in Chemistry or related fields
• 5 or more years of relevant experience in cGMP environment
• Familiar with cGMP, GLP and Data Integrity
• Familiar with analytical chemistry, laboratory instrumentation & troubleshooting
• Familiar with Empower software
• Good technical writing skills & ability to write laboratory investigation reports, technical reports and procedures

Nice-to-Have

• People management skills
• Experience in regulatory inspections

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

Pfizer