QC Chemical Compliance Specialist (Fixed Term)
About this position
The QC Chemical Compliance Specialist will be responsible for ensuring compliance with regulatory requirements, managing compendia compliance, and maintaining laboratory documentation in accordance with Pfizer Quality Standards.
Responsibilities
• 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 testingManage 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 such as submitting safety incident and complete 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 con
Requirements
• Bachelor's Degree (Chemistry or Pharmacy)
• Min 1 year experience in analytical method development/validation will be preferred
• Strong 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 manufacturing
• Good analytical thinking and high-level integrity
• Able to work well either as an individual or as a team member
• Excellent interpersonal and communication skills