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's 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- 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 analyt at the same time when testing activities are performed. Ensure analyst follow the ALCOA principles.
- Review product and raw material results.
- Work closely with key QA, Production, Engineering and EHS personnel to support them in laboratory testing and trouble-shooting 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.
Leaders Accountabilities- 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.
- 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.
Job Related Requirements- Demonstrated leadership and customer service skills.
- Effective problem solving skills.
- Excellent verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team and matrix management function.
- Demonstrated leadership and management potential, innovative and strategic thinking ability.
- Comprehensive knowledge of cGMPs and appropriate regulations.
- Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.
- Experience in Empower software/ SAP will be an added advantage.
Accountability- Analytical Testing.
- Staff Development.
- Performance Review.
- Laboratory Non-conformance and Investigation management.
- Laboratory safety and housekeeping
- Procedures Development & Review
- Training
- Change Control Implementation
Key Performance Indicators (KPIs)- Safety Performance.
- New Procedures/SOPs implementation.
- Lead time for QC testing.
- Budget control.
- Project Milestones and Implementation.
- Compliance to GMP/GLP requirements.
- Timely completion of training.
- Timely laboratory investigation
Qualifications- Bachelor or Master or Ph.D degree in Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmacutical Science or Microbiology or a related science.
For QC Supervisor - Not less than 5 years' experience working in a chemical laboratory, preferably within the pharmaceutical industry and with experience in managing/supervising small 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 PremisePfizer 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