Quality Assurance System (1 year fixed term contract)

QA System

PURPOSE

As core function for Bayer Cimanggis plant unit on assuring the compliance of Bayer and authority regulations related with GxP, Computerized System Validation (CSV), Qualifications activities, Data Integrity and managing the technical system and computerized system life cycle (including calibration) which consists of but not limited to Commissioning-Decommissioning activities.
 

KEY TASKS

• Ensure the Technical System lifecycle is implemented according to the updated SOP
• Conduct the review of the technical system lifecycle document consists of B-review, Quality Impact Assessment, URS, Functional Specification, Risk Assessment, Commissioning Document (GMP Relevant), Qualification Document 
• Coordinating with the technical system owner and project lead according to technical system life cycle activities.
• Issue/update the site Qualification Master Plans, CSV Master Plan (including the inventory) & data related with the Technical System in GMP areas.
• Monitor the progress of qualification, calibration and CSV activities as per scheduled on VMP and update management on regular basis systematically following plan to outline any potential constraints, gaps in asking supports (resources) for improvement or solving problem.
• Execute qualification, GxP IT Infrastructure qualification and computerized system validation activities that has been scheduled with timely manner.
• Conduct review calibration report and create tag calibration status.
• Conduct periodic review related to Technical System
• Maintain CAPA related to Technical System and Computerized System Validation.

SKILLS AND REQUIREMENTS

• Experience in GMP (Good Manufacturing Practices) and Quality Assurance; fresh graduates are welcome to apply.
• Familiarity with both international and local GMP standards for pharmaceutical manufacturing, including Halal requirements and food supplements.
• A collaborative team player who can also work independently and achieve results with minimal supervision.
• Strong attention to detail and a commitment to delivering high-quality work.
• Proven leadership experience in managing teams effectively.
• Proficient in professional English and comfortable working within an international team environment.
• Excellent problem-solving skills and the ability to address challenges effectively.
• Strong organizational and time management abilities to handle multiple tasks efficiently.

Bayer Indonesia is committed to building a diverse, equitable, and inclusive workforce. We believe that diversity in all its forms enriches our company culture, expands our perspectives, and drives innovation. We welcome and encourage applicants of all backgrounds, divisions, experiences, and identities to apply for the positions