Lowongan Change Management Officer di PT Bayer Indonesia

JOB PURPOSE

• To support the Change Management Specialist and as the Subject Matter Expert (SME), coordinator or the executor of the implementation change management and the action task related with change in PT Bayer Indonesia

YOUR TASKS AND RESPONSIBILITIES

• Responsible to maintain surveillance of change management system
• Act the single point of entry for assigned Technical Change Requests
• Initiate the review process by calling in a team of experts from different function such as Quality, Technical Support and Project Management, Supply Chain, Operations, Regulatory Affairs, etc.
• Lead and motivate the teams for reviewing through implementation to completion of the change
• Ensure that all changes related to process, procedure, equipment, material, and facility that have potential impact to the quality, safety, and effectiveness of the product evaluated and approved before implementation
• Ensure that all aspect for the implementation of a change are adequately documented and corresponding activities are defined assigned by setting up the task list/timeline considering stakeholder’s feedback and all potential impact of the change on the product and its supply
• 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, HALAL, SMK3)
• Ensure 100% CMS implementation
• 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
• Monitoring task list to ensure is implemented according to defined dates and objectives
• Monitoring KPIs on Change Management Performance
• Support Change Management & Material Change Source Project Specialist in reporting progress report of Quality Management review in monthly basis
• 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
• 1 years’ experience in GMP aspects or related with the food supplement or drug manufacturing
• Having deep knowledge related with the qualification activities requirements
• Having knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System
• Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes). Be familiar with BHC GMP Policies and Directives through training to enable controlling implementation into local practices
• Skilled to work within an international team and has ability to work within team
• Having good Leadership experience
• Professional English skills
• Can operate the computer program (Microsoft office)
• Be able to resist any influence, which would hamper management decision making
• Able to resist any influence, which would hamper management decision making during the absence of QA System Manager
• Having high motivation to learn a new things
• Having good writing and communication skill both in English and Bahasa
• Having good skills on teach the team