Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
YOUR KEY TASK & RESPONSIBILITIES
- Coordinate the Technical System lifecyle are implemented according to the updated SOP.
- Preparing related document about Qualification activities (e.g. Qualification Plan, Qualification Protocol, and Qualification Report) according to the respective SOP.
- Coordinate with other department (e.g. Engineering, Project, Quality, Operations, Supply Chain Management (SCM), Health Safety and Environment (HSE), and Technical Supply Management (TSM) that has Technical System issue, such as new installation / modification / relocation / retirement. And also coordinate with project lead related vendor schedule.
- Execute qualification activities that has been scheduled with timely manner.
- Monitor and control the calibration schedule in Cimanggis and ensure there are no overdue or uncalibrated status in critical parameter of technical system.
- Conduct review calibration report and create tag calibration status.
- Perform evaluation/investigation of deviations results related with the qualification issue.
- Create and/or review of procedures (e.g. SOPs and templates) related to technical system lifecylce topic to ensure the procedures are aligned with the updated requirement (e.g.: CMS (Bayer Regulation: GOI, GSOP, Supplement, Best Practices, Local regulation such as CPOB, PICs).
- Follow up the CAPA recommendation from validation activities in Dev@com System, and ensure the CAPA recommendation from validations are closed timely manner.
- Follow up the CAPA recommendation from event/deviation/risk assessment in Dev@com system and enure the CAPA recommendation are closed timely manner.
- Educate related person who relevant with qualification activities.
- As a proxy of Qualification Supervisor if the Supervisor is not available.
WHO YOU ARE
- Bachelor degree in Pharmacy / Apothecary / Chemical Engineering / Industrial Engineering or related area.
- Having 1+ experience in GMP aspectes related with food supplement or drug manufacturing/fresh graduate is still applicable.
- Having knowledge related with the manufacturing, packaging and cleaning validations requirements.
- Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
- Skilled to work within an international team and ability to work within teams.
- Good English skills.
- Having high motivation to learn a new things
- Having good writing and communication skill both in English and Bahasa
Reference Code: 208568
Functional Area: Quality