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. Your knowledge of quality control will be helpful to support our quality programs. Your ability to analyze chemical, biological or microbiological products will help us manage our quality. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to its patients.
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Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
The QC Chemist will serve as a member of the Reference Standards team that will hold the responsibility for the testing and release of reference standards within the Scientific and Laboratory Services (SLS) Reference Standards team. The incumbent must have a strong technical background in analytical instrumentation and troubleshooting.
- Review testing protocols.
- Create and/or review instrument methods (e.g. Empower).
- Execute testing and troubleshooting.
- Preparation of Certificate or Analysis (COA)
- Calibrate and maintain assigned equipment.
- Support analysts on troubleshooting methods and instruments.
- Review laboratory data and records.
- Participate in tier meetings and assigned committees (such as Safety committee).
- Draft and perform investigations for questionable or OOS results when required.
- Support and/or lead change controls associated with reference standard certification.
- Draft, review and revise testing notes and standard operating procedures (SOP) pertaining to reference standard certification & laboratory documentation.
- Support audits/inspections when required.
- Support and/or lead internal quality and safety compliance programme.
- Any other tasks as assigned by supervisor based on business needs.
Qualifications
More than 5 years experience working in a GMP laboratory setting.
Core competencies:
- Strong cGMP & GDP foundation and understanding of ALCOA principles
- Good knowledge on compendial requirements and ICH guidelines
- Familiarity with Empower system
- Hands on experience with analytical instruments such as HPLC, GC, TGA, DSC, etc.
- Critical thinking skills & troubleshooting skills
- Adaptable to dynamic work environment
- Strong oral and written communication skills
- Independent & self-motivated/driven
- Effective team player
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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