Quality Assurance System (1 year fixed term contract)

Bayer (Indonesia) (Cimanggis, West Java, Indonesia)

West Java, Indonesia

Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. We design our products and services to serve the most essential human needs of health and nutrition. At the same time, we strive to address some of the world’s biggest challenges presented by a growing and aging global population. At Bayer, we’re committed to driving sustainable development and generate a positive impact with our businesses. Through the power of science, we’re pioneering new possibilities that advance life for all of us. That means reimagining how we care for ourselves and one another by empowering everyday health, improving approaches to patient care, and finding better ways to nourish our communities around the world.

About this position

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).

Responsibilities

• 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.

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.