Senior QC Chemist

4 weeks ago

Singapur, Singapore Pfizer Full time

Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of Pfizer Asia Manufacturing Pte Ltd (PAMPL) in Singapore

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. 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 Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

POSITION SUMMARY

The incumbent is a member of the Quality Control (QC) Laboratory team. Under the supervision of the QC Manager / Supervisor, the key responsibilities are:

Review and approval of QC sample/lot disposition in the QC Laboratory. Work with the different QC team to ensure products are tested and released within the stipulated timeline. Owns the capacity planning and work forecast to ensure optimal efficiency in resource utilization. Conduct and support laboratory investigations. Represent QC to participate in monthly EHS safety meeting, and be the QC lead to drive the safety culture in QC laboratory. Set up and maintain QC processes (e.g. Sample lot disposition, reference standard and retention samples management). Author SOPs other GMP documentation

Use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

How You Will Achieve It

Perform quality review of completed test records ensuring strict adherence to ALCOA principles and Data Integrity (DI) requirements. Perform Approval of QC samples/lot disposition in the Laboratory Information Management System (gLIMS) and release of API, intermediates, raw materials, solvents and packaging materials. Ensure prompt approval of QC samples as per Service Level Agreement for the different products and escalate any potential delay to the different functions. Create and maintain the QC testing capacity model to forecast incoming samples for all materials against available capacity and to highlight any constraints to management. Generate reports on schedule adherence and other KPIs to overall QC Operational efficiency. Represent QC in cross functional meeting to ensure products (API, intermediates and RM) required are incorporated into QC operational testing schedule. Represent QC in New Product Introduction meeting to ensure all operational issues noted are escalated and resolved. Highlight any abnormalities detected during review and raise laboratory investigations as required. Conduct laboratory investigations in regard to testing, reference standards and API release where required and ensure all follow up actions are completed. Author SOPs and other GMP documentation (e.g. trend reports). Lead and maintain 5S culture, practice good housekeeping and ensuring all safety procedures are followed.  Conduct training for fellow colleagues from QC and other departments (e.g. Production). Uphold Pfizer's code of conduct and values. Collaborate with cross-functional teams to drive flawless execution. Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalations. Support development and implementation of solutions. Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated.

Qualifications

Must-Have

Bachelor's Degree 8 years QC experience in a CGMP analytical laboratory or 5 years QC experience in the pharmaceutical industry is required Effective problem solving skills  Demonstrated leadership and interpersonal communication skills Teamplayer and action oriented Knowledge of cGMPs and ALCOA principles  Possess a can-do / pride to succeed attitude Embrace the use of digital technology to scale and speed up every form of interaction and action

Nice-to-Have

Master's degree Relevant pharmaceutical experience Experience in gLIMS/SAP will be an added advantage. Knowledge of computer system hardware, infrastructure and networks

 
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#LI-PFE

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