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 (Systems) will serve as a member of the Reference Standards team that will hold the responsibility for the system administration, validation and support for software applications within the Scientific and Laboratory Services (SLS) Reference Standards team. The incumbent must have a strong technical background in computer applications used in an analytical laboratory setting and understands current regulatory expectations including cGMP requirements and 21 CFR Part 11 and Annex 11.
- Lead the validation of new or updated laboratory computer applications, including, but not limited to, installation qualifications, system configuration, Electronic Records and Electronic Signature (ERES) assessments, data backup verifications and audit trail reviews.
- Draft computer application testing protocols and related documentation in accordance to Pfizer policies, procedures and relevant regulations and requirements.
- System Administration for computer applications for SLS Singapore laboratory.
- Troubleshoot technical issues, assist laboratory personnel with system issues, perform computer system periodic reviews and periodic system audit log reviews.
- Provide oversight for service providers who performs qualification, calibration/preventative maintenance for laboratory instrumentation used for GMP testing, and review the associated documentation.
- Responsible for scheduling and managing calibration/maintenance service contracts with external vendors.
- Perform investigations for non-conformances associated with laboratory equipment when required.
- Ensure compliance to Quality Agreement between SLS and other qualified testing laboratories.
- Support and/or lead change controls associated with computer system and/or laboratory instrumentation.
- Draft, review and revise standard operating procedures (SOP) pertaining to computer systems and/or laboratory instrumentation.
- Support audits/inspections.
- Support and/or lead internal quality and safety compliance programme.
- Any other tasks as assigned by supervisor based on business needs.
Qualifications
Must-Have
- Degree in Computer Science, Chemistry or related technical fields.
- A few years experience working with computer applications (e.g. NuGenesis, Empower, etc.) in a laboratory setting. Familiarity with laboratory instrumentation would be preferred.
- Strong cGMP & GDP foundation and understanding of ALCOA principles
- Good knowledge on 21 CFR Part 11 and Annex 11
- Familiarity with network infrastructure
- 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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