Back to job search

QC Chemical Compliance Specialist (Fixed Term)

Pfizer (Indonesia)
Pfizer (Indonesia) (Jakarta)
Jakarta
DKI Jakarta, Indonesia 🇮🇩
Pfizer (Indonesia)
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best-known consumer healthcare brands. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time.

About this position

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.

Responsibilities

• 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

Requirements

• 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

Benefits

\
Huneety A.I Salary Estimate
3,000,000 - 8,000,000 IDR per month