Lowongan Change & Documentation Supervisor di PT Bayer Indonesia

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 the tasks of the QA System Manager in the process of change management
• Control all of GMP documents so the documentation can be performed properly and correctly
• Support internal and external audit process in term of change management and documentation area
• Ensure and review the implementation of yearly GMP Training plan
• Ensure no overdue SOP in each area/ department
• Control electronic and non-electronic documents so that only effective/ valid documents are located in the Cimanggis Site
• 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
• Support of internal and external audit in PT Bayer, Cimanggis Site performed in timely manner
• Ensure 100% CMS implementation in change management and documentation management area
• 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 ensure the CAPA recommendation are closed timely manner
• Ensure that CAPA as result of audit in Documentation area are completely finished in timely manner
• Quality Management Review (QMR) supported data from Change Management and Documentation Area in timely manner
• Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department
• 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

WHO YOU ARE

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