Manufacturing Risk Control
Purpose
Manufacturing Risk Control of the Operations Departement at PT Bayer Indonesia Cimanggis plant, is responsible to deploy of the Asset Ownership framework with risk based approach to ensure consistent and rigorous application across the business process. Responsible for successful management and implementation Safety, Quality, Compliance and Performance requirement in manufacturing to support business continuity. Manage all GMP Compliance documentation and its related plans in order to support quality improvement and documentation activities in accordance with Bayer manufacturing directions, current Good Manufacturing Practice (cGMP) principles, Environmental, Health & Safety (SHE) principles and regulations as specified by local FDA (BPOM = Badan Pengawasan Obat dan Makanan).
Major Tasks
- Responsible leading activity GMP Self Inspection, 5S inspection, Internal / external audit by making action plans, timelines and arranging effective solutions of all relevant findings with the Manufacturing Business Unit area.
- Help supervise GMP training for personnel in the Department Manufacturing Business Unit following the applicable SOP. And help provide user access and user rights for the Manufacturing Business Unit organization.
- Lead and execute the effective closure of all corrective and preventive actions by performing investigation and recommendation through Deviation Control.
- Memimpin dan melaksanakan penutupan yang efektif dari semua tindakan korektif dan preventif dengan melakukan investigasi dan rekomendasi melalui Deviation Control
- Instill and sustainably promote the OE culture in the team. Take part in continuous progress activities to promote efficiency, cost efficinecy and reduce non-value in the team.
- Ensure general knowledge of cGMP and pharmacy for itself is kept up to date.
- Constantly providing escalation / communication in a timely and effective manner, building trust and honesty in work relations and instilling a methodology right from the start (right first time) in the team.
- To maintain the availability of sticker labels in Operation and to reconcile forms and labels for the production process in the system.
- Responsible for management training topics for personnel in the Manufacturing Business Unit area, both training curricula management, perform training and refresh training SOP.
- Perform operations activities to run properly and efficiently according with SOP, department objective,GxP requirement and HSE rules.
- Organize and execute all projects related GMP compliance in Manufacturing Business Unit area in timely manner.
- Execute all related to SOPs and master MBRs (Master Batch Record) in Manufacturing Business Unit area according to routine review document, its training, process improvement, audit findings and relevant review process.
- Execute and monitor completion of plans & actions as agreed timeline related to change management, deviation, product complaint, validation, data integrity, qualification, and other investigations in production following valid SOP.
- Execute completion of raw material changes in production (including handling the BOM and ID test form for semi-finished good of consumer health & pharma products)
- Perform GMP and safety training for personnel in the production area following the applicable SOP.
- Partake and generate need for involvement in self-development of leadership skill.
- Ensure the implementation of Assest Ownership on the team runs well. Responsible as PSS representative in Manufacturing Business Unit organization
- Prepare an updated batch record for the Manufacturing Business Unit process. Provide all documents needs for Manufacturing Business Unit process, especially for copy master batch records, logbooks, forms, and labels.
- Support to generate and monitor tracking of batch record review lead time. Complete Batch Record reviews in a timely manner and fulfill KPI sites, including conducting daily scrum board discussions with key colleagues. Ensuring daily responsibilities and targets are followed up to ensure sustainability, with involvement from the Manufacturing Risk Control team
- Preparing and reviewing the 'recipe pas X' as a standard reference for the production process, to ensure risk control, quality consistency, and compliance with manufacturing specifications.
Skills & Requirements
- Be familiar with Bayer procedures, cGMP, POM regulations, occupational safety and health, and management in relation to production of Bayer.
- To have a proficiency in Indonesia and English.
- Good communication skill, strong leadership, result orientation is a must.
- Be able to resist any influence which would hamper management decision making.
Application Period:
18/07/2025
Reference Code:
849926
Division:
Consumer Health
Location:
Indonesia : West Java : Cimanggis
Functional Area:
Production&Manufacturing
Position Grade:
R.11
Employment Type:
Regular
Work Time:
Standard
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