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Qc Chemical Compliance Specialist

3 meses atrás


Castelo Branco, Portugal Pfizer Tempo inteiro

.QC Chemical Compliance Specialist (Fixed Term) Apply 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 Your 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 It The 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 Quality Control Manager and/or QC Chemical 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 Lab. Execute the project (i.E method validation/verification, etc.) in QC Chemical Lab in the most effective way and meet the target date. Ensure all reagent, reference standards, and equipment are ready for testing. Manage the method validation and testing execution by external lab. Prepare analytical method validation/verification protocol and report, and study in QC Chemical Lab. Support QC Compliance Supervisor to manage and maintain the implementation of compendia compliance in QC Area. Ensure the compliance in Quality and Safety by submitting safety incident reports and completing CAPA as per commitment date. Manage change control related to process and documentation for laboratory compliance activities. Maintain QC Laboratory documentation (including registration dossier related to laboratory document) in QC Lab. Support team to conduct and prepare laboratory investigation and manufacturing investigation reports. Perform training to QC Lab personnel, as required. Qualifications Must-Have - Bachelor's Degree (Chemistry or Pharmacy)- Min 1 year experience in analytical method development/validation preferred