QC Laboratory Compliance Supervisor- Data Integrity

Pfizer

4.1

(94)

Jakarta, Indonesia

Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction
  • 4.6/5 in supportive management
  • 78% say women are treated fairly and equally to men
  • 79% would recommend this company to other women
  • 81% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)
  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative
  • #4901741

    Position summary

    and approve protocol and report of qualification of laboratory instrument

    • Guide and accompany analyst during qualification of laboratory instrument

    • Review computerized system validation result in the QC Laboratory

    • Perform periodic review related to audit trail, user privilege, back-up, restore and data integrity gap assessment for instrument and QC documents

    • Hold and maintain administrator account in equipment and instrument in QC Laboratory

    • Maintain QC Laboratory documentation and doing Laboratory investigation, Manufacturing investigation and closure of all commitments.

    • Manage calibration activities and review calibration/verification report

    • Manage curricula and training assignment, and ensure training completion in QC Laboratory

    • Revise SOP, STP and other GMP document in QC Laboratory, as required

    • Perform training to QC Laboratory Personnel, as required

    Qualifications

    Must-Have

    • Graduate from Faculty of Pharmacy or Chemical Science (S1, Undergraduate Degree)

    • 3+ years' experience

    • Laboratory supervisory experience

    • Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories

    • Experience with leading colleagues and/or projects

    • Strong people management experience

    • Demonstrated skills in collaboration, attention to detail, and communication skills

    • Ability to handle complex and detailed situations with a focus on quality

    Nice-to-Have

    • Master's degree

    • Six sigma certified

    • Relevant pharmaceutical experience.

    • Experience with microbiological risk assessments

    • Knowledge of Laboratory Information Management System Empower and Microsoft Office

    • Working knowledge and understanding of requirements as it relates to method qualification and testing of components and finished products

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

    Quality Assurance and Control

    #LI-PFE

    Why you should apply for a job to Pfizer:

  • 4.1/5 in overall job satisfaction
  • 4.6/5 in supportive management
  • 78% say women are treated fairly and equally to men
  • 79% would recommend this company to other women
  • 81% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • 23-25 Week Maternity Leave (Fully paid for birth parents)
  • Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
  • Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative