Change & Documentation Supervisor Jobs

JOB PURPOSE

• Ensure that all the implementation of change is well managed
• Periodically archive and review both manually system and online system for all of the GMP’s documents. Coordinate with all departments to ensure all of GMP documents are in effective status and align with Bayer Healthcare Compliance Management System

Your Tasks And Responsibilities

• Support of internal and external audit in PT Bayer, Cimanggis Site performed in timely manner
• Coordinating to evaluate HIRA (Hazard Identification Risk Assessment) of working area and ensure the completeness of HIRA training on the team and implementation of HIRA
• Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department
• Ensure no overdue SOP in each area/ department
• Ensure and review the implementation of yearly GMP Training plan
• Control all of GMP documents so the documentation can be performed properly and correctly
• Follow up the CAPA recommendation from event/deviation/risk assessment in Dev@com system and ensure the CAPA recommendation are closed timely manner
• Quality Management Review (QMR) supported data from Change Management and Documentation Area in timely manner
• Support the tasks of the QA System Manager in the process of change management
• Ensure GxP System Implementation as controlled document performed properly and correctly
• Writing and/ reviewing SOPs in Change Management and Documentation area and updated in line with the newest version of related GSOP
• Follow up the CAPA recommendation from validation activities in Dev@com System, and ensure the CAPA recommendation from validations are closed timely manner
• Support internal and external audit process in term of change management and documentation area
• Ensure that CAPA as result of audit in Documentation area are completely finished in timely manner
• Ensure 100% CMS implementation in change management and documentation management area
• Control electronic and non-electronic documents so that only effective/ valid documents are located in the Cimanggis Site

Who You Are

• Proficiency in oral and written in English
• Understands and familiar with current GMP
• Able to work with timeline
• Able to work under pressure
• Mastering computer operation for standard office
• Have good personality
• Have good skill in leadership and communication
• Bachelor degree in Pharmacy / Apothecary / Chemical Engineering / Industrial Engineering
• Has ability to work within team
• Have ability to create SOP and or other GxP documents
• Have good initiative
• 3+ years’ experience in GMP aspects or related with the food supplement or drug manufacturing
• Have good integrity

Application Period: 30 August 2023 - 12 September 2023 Reference Code: 800334

Division: Consumer Health Location: Cimanggis - Depok

Functional Area: Quality Position Grade: R12

Employment Type: Permanent Work Time: Flexi Hours - 8 working hours

Contact Us

Address Telephone E-Mail

PT Bayer Indonesia

Menara Astra, 33rd floor

Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia

+622130491111

[email protected]