QC Chemical Compliance Specialist (Fixed Term)
เกี่ยวกับตำแหน่งนี้
The QC Chemical Compliance Specialist will be responsible for managing compendia compliance, laboratory documentation, method validation/verification activities, and ensuring current GMP practices in QC Laboratories comply with Pfizer Quality Standard/cGMP. The role involves assisting in writing or updating SOPs and STPs, executing projects in the most effective way, and supporting the QC Compliance Supervisor in maintaining compendia compliance.
หน้าที่รับผิดชอบ
• Assist Quality Control Manager and/or QC Chemical Compliance Supervisor in writing or updating SOPs and STPs
• Execute projects in QC Chemical Lab effectively and meet target dates
• Ensure readiness of reagents, reference standards, and equipment for testing
• Manage method validation and testing execution by external lab
• Prepare analytical method validation/verification protocol and report in QC Chemical Lab
• Support QC Compliance Supervisor in managing and maintaining compendia compliance in QC
• Ensure compliance in Quality and Safety by submitting safety incidents and completing CAPA
• Manage change control related to process and documentation for laboratory compliance activities
• Maintain QC Laboratory documentation in QC Lab
• Support team in conducting and preparing laboratory investigation and manufacturing investigation reports
• Perform training for QC Lab personnel as required
คุณสมบัติ
• Bachelor's Degree in Chemistry or Pharmacy
• Min 1 year experience in analytical method development/validation preferred
• Strong knowledge of analytical instruments and various test procedures
• Knowledge of regulatory compliance requirements for Pharmaceutical manufacturing
• Good analytical thinking and high-level integrity
• Ability to work well as an individual or as a team member