QC Chemical Compliance Specialist

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 AchieveYour prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.As laboratory compliance specialist, 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 commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve ItThe role is accountable to manage compendia compliance, laboratory documentation, method validation/ verification activities, and ensure that current GMP practice in QC Laboratories comply against Pfizer Quality Standard/cGMP, not limited to:Assist QC Manager and/or QC Lab Compliance Supervisor for writing or updating Standard Operating Procedure (SOP) and Standard test procedures (STP) in accordance with actual practices, PQS, current GMP, and regulatory requirements, in QC Chemical LabExecute the project (i.e method validation/verification, etc.) in QC Laboratory Compliance Team in the most effective way and meet the target datePrepare analytical method validation/ verification protocol and report, and study in QC Chemical areaSupport QC Lab Compliance Supervisor to manage and maintain the implementation of compendia compliance in QC ChemicalEnsure the compliance in Quality and Safety by such as submitting safety incident and CAPA as per commitment dateMaintain QC Laboratory documentation (including registration dossier related to laboratory document) in QC Chemical LabSupport QC Operation team in laboratory investigation in case of out of specificationEnsure all reagent, reference standards, and equipment are ready for testingPerform training to QC Lab personnel, as requiredQualificationsMust-HaveBachelor's Degree (Chemistry or Pharmacy)Min 1 year experience in analytical method development/validation will be preferredStrong knowledge about analytical instruments and various test procedure, including as in most current compendia (FI, USP, BP, etc.)Knowledge of regulatory compliance requirements for Pharmaceutical manufacturingGood analytical thinking and high-level integrityAble to work well either as an individual or as a team memberExcellent interpersonal and communication skillsNice-to-HaveGood knowledge of dossier and product registration processWork 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