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 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.How You Will Achieve ItThe Senior QC Chemist will serve as a senior member of the Reference Standards team that will hold the responsibility of planning, defining, implementing and maintaining the end to end process of reference standards certification and recertification for the Pfizer network. In addition to providing guidance to junior members in the team, the incumbent is also expected to lead and collaborate with other sub-teams, which includes but not limited to distribution team, investigation team and QA team, to ensure on time recertification of reference standards in a safe and compliant manner.

• Has good knowledge on compendial requirements, ICH guidelines, etc..
• Support sourcing of new lots of reference standard material from PGS sites and external vendors as well as introduce new entities from Pfizer AR&D, Global Technology and Engineering (GT&E) and/or Pfizer External Supply Quality (ESQ) into Pfizer Small Molecule Reference Standards Programme.
• Draft or review and approve Reference standard testing protocols and related documentation in accordance to Pfizer policies, procedures and relevant regulations and requirements.
• Demonstrate good understanding on various analytical techniques (e.g. FTIR, KF, PT, LC, GC etc.) and able to guide analyst on troubleshooting.
• Review completed data packages and prepare/issue certificate of analysis (COA) and/or certificate of conformanace (COC)
• Collaborate with QA to release reference standard material for use before stop use date.
• Support and/or lead lab investigations on questionable results or out of specifications results as and when required.
• Support and/or lead change controls associated with testing.
• Draft, review and revise standard operating procedures (SOP) pertaining to reference standard sourcing, certification and laboratory instrumentation.
• Support audits/inspections.
• Act as trainer for new or junior members of the team when necessary.
• Support and/or lead internal quality and safety compliance programme.
• Support the tracking of team performance matrices.
• Any other tasks as assigned by supervisor based on business needs.

QualificationsMust-Have

• Degree in Chemistry or related fields, preferably in analytical chemistry/instrumentation.
• More than 5 years relevant QC testing experience, preferably in pharmaceutical industry.
• Strong cGMP & GDP foundation and understanding of ALCOA principles
• Basic understanding of organic chemistry
• Ability to search Pfizer system (PDOCs, GDMS, etc.) and the ability use programs like Scifinder
• good knowledge of analytical techniques/instrumentation
• critical thinking skills & troubleshooting skills
• adaptable to dynamic work environment
• excellent oral, written and facilitation skills
• independent & self-motivated/driven
• effective team player
• demonstrate accountability and leadership qualities

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