Qc Compliance Specialist - Data Integrity

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will have the all important role of conducting internal audits of R&D and Quality laboratories, prior to the audit by regulatory agencies. You will be relied on to make sure that they comply with the policies, procedures and practices laid down by the regulatory agencies. Your attention to detail will help us report discrepancies in product safety and recommend appropriate corrective actions. You will help the laboratory management to establish practices and procedures prior to audits.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Perform data integrity assessment for laboratory equipment and activities
• Perform training to QC Laboratory personnel as OJT Trainer
• Lead the Continuous Improvement (CI) process for the Integrated Manufacturing Excellence (IMEx) within the QC laboratory, identify and conduct continual improvement project.
• Develop good working practices/guidelines to work as tools to assist staff in the use of quality system Standard Operating Procedures.
• Maintain Laboratory area, equipment, facilities in a clean, orderly and operational state.
• Prepare protocol and report for qualification of laboratory equipment, laboratory computerized system and spreadsheet.
• Execute computerized system and spreadsheet validation in the QC Laboratory
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Guide and accompany analyst and vendor technician during qualification of laboratory equipment, laboratory computerized system and spreadsheet in the QC Laboratory
• Maintain compliance in Quality and EHS by supporting Laboratory Compliance Supervisor in maintaining QC Laboratory documentation and doing Laboratory investigation, Manufacturing investigation, closure of all commitments.

Qualifications

Must-Have

• Good working knowledge of common laboratory databases
• Good initiative, proactive, conflict management skill, good interpersonal skill, team player
• Knowledge of regulatory compliance requirements for Pharmaceutical manufacturing
• Able to work well either as an individual or as a team member
• Good analytical thinking and high-level integrity
• Excellent interpersonal and communication skills
• Bachelor's Degree from Faculty of Pharmacy or Chemical Science (S1- Undergraduate Degree)

Nice-to-Have

• Experience in a pharmaceutical laboratory and equipment

Work Location

• Pasar Rebo, East Jakarta

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