QA System (Contract)

PURPOSE

As a core function for the Bayer Cimanggis plant unit, assuring compliance with Bayer and authority regulations related to GxP, Computerized System Validation (CSV), qualification activities, and managing the technical system and computerized system life cycle (including calibration), which consists of, but is not limited to, commissioning-decommissioning activities.

MAJOR TASKS

• Ensure the technical system lifecycle is implemented according to the updated SOP by performing qualification of the technical system and maintaining its requalification status.
• Coordinate with the technical system owner and project lead according to technical system life cycle activities.
• Assure all quality aspects are appropriately addressed during GxP Computerized System Validation activities.
• Execute qualification, GxP IT infrastructure qualification, and computerized system validation activities that have been scheduled in a timely manner.
• Conduct a review of calibration reports and create tag calibration status.
• Conduct periodic reviews related to the technical system.
• Execute CAPA related to the technical system and Computerized System Validation.
• Serve as the Local Subject Matter Expert (Local SME) for the ValGenesis System (a system for qualification and validation activities and documentation).
• Explore to identify and propose continuous improvement of quality aspects with implementation in the QA System area.
• Upgrade oneself in management and professional skills, including developing the team, especially on GMP aspects.
• Support maintaining appropriate precautions on occupational safety and health, as well as the security of facilities within the Quality Department.
• Coordinate to evaluate OHSERA (Occupational Health Safety and Environment Hazard Identification Risk Assessment) of the working area and ensure the completeness of training for the team and implementation of OHSERA.

SKILLS & REQUIREMENTS

• Pharmacist with a minimum of 1 year of experience in GMP aspects and Quality Assurance.
• Familiar with international and local GMP principles for the manufacturing of pharmaceutical products and food supplements.
• A team player who is also able to work independently and deliver results with minimal guidance.
• Attention to detail and a focus on the quality of work.
• Professional English skills and skilled in working within an international team.
• Good problem-solving abilities.
• Good organizational and time management skills.
• Proven flexibility and adaptability.