QC Chemical Compliance Specialist (Fixed Term)

Pfizer (Indonesia)

Pfizer (Indonesia) (Jakarta)

Jakarta

DKI Jakarta, อินโดนีเซีย

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.

คลิกเพื่อดูงานที่คล้านกันในประเทศ อินโดนีเซีย:

ฝ่าย: การจัดการคุณภาพ

อุตสาหกรรม: การดูแลสุขภาพและการแพทย์ เภสัชกรรม

เกี่ยวกับตำแหน่งนี้

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.

หน้าที่รับผิดชอบ

• 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

คุณสมบัติ

• 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

สิทธิประโยชน์

Huneety A.I Salary Estimate

3,000,000 - 8,000,000 IDR per month