Job Purpose

Will demonstrate the initiatives and leading role in implementation and coordination to make the change for the manufacturing documentation, Device Master Records, SOPs and support for change control task.

The role will take lead in Hygiene and GMP compliance activities at Medical Plant, maintain and ensure the SOP of Microbiology and Endotoxin Product Families and related annexes for all Product Group in BBVN MD are updated according to change control and improvement.

Key Responsibilities

1. Manufacturing Documentation (30%)

• Lead and coordinate with stakeholders to update the manufacturing document to fit with the current production status (Manufacturing Process Documentation, SOP, Device Master Record).
• Take care of change control task related to the documentation to ensure the compliance and consistency.
• Ensure the training of the employees after the change of the documentation.
• Ensure the proper storage in production.
• Identify the good practice from the production sections and make plan and coordinate the implementation of such practices across areas in the production team.
• Make a improvement proposal for SOPs or Guidelines to make them consistent, applicable and practical to production as well as audit requirements.
• Present the documentation during the Audit.

2. Microbiology and Endotoxin Documentation (30%)

• Lead and coordinate with the other department to create and maintain the SOP of Microbiological Product Families, the respective Microbiological Product Families and Endotoxin Product Families including the Matrix and Appendix.
• Take care of change control task related to the documentation of Microbiological Product Families and Endotoxin Product Families.
• Coordinate with related team for training other employees to maintain the documentation.

3. Hygiene / GMP (20%)

• Develop and maintain a report for the Hygiene Program.
• Lead the improvement action plan related to Hygiene.
• Lead the A3 related to the CFU Deviation / Hygiene Program Deviation.
• Train and prepare training document for Hygiene or GMP training.
• Make a document to support the GMP yearly training accordingly with the staff coordinator.
• Be a trainer for the yearly GMP training for the production staff.
• Ensure the tracking and monitoring of GMP training in accordance with Group/company and audit requirement.

4. Change Control / DP-CR (10%)

• Participate to the Kick Off meeting for the change control which affect BBVN to define the correct task responsible.
• Understand the change control and identify the task owner from production and follow up with task owner for the completion of the requirements.
• Follow up the DP/CR led by production, prepare reports and actions for completion on time in full.

5. Other Activities (10%)

• Reporting, data consolidation for Manufacturing Documentation Update.
• Support for training matrix update for Section Manager and Production Manager and the cross department training matrix.
• Other tasks as requested.

Job Functions

• Lead and coordinate the update of the manufacturing documentation, SOP, Device Master Record.
• Lead Hygiene and GMP compliance activities at Medical Plant.
• Lead the improvement activities of the quality of the manufacturing documentation and SOP.
• Support change control Kick Off Meeting, Training Matrix Update, GMP documentation and training, production tour.
• Other tasks as required.

Reporting Line

• Direct report to: Manager – Medical Production

Qualifications

Education

• Bachelor’s Degree in Microbiology, Biotechnology, Pharmacy, Chemical Engineering, Food Technology or other related scientific disciplines (Industrial Engineering, Quality Management, Environmental Science, General Engineering).
• English Communication.

Experience

• At least 2 years of experience in SOP writing and updating, and change control within a manufacturing environment under GMP standards.

Nice to have:

• Microbiology / biotech background, experience with endotoxin / hygiene monitoring.
• Knowledge of ISO 13485.
• Lean Six Sigma.

Key Skills

• Good command of English (written and spoken).
• Clear and concise communication.
• Strong attention to detail.
• Problem-solving skills.
• Continuous improvement mindset.
• Strong coordination skills (cross-functional collaboration with QA, QC, and Production).
• Strong documentation and organizational skills.

Internal Stakeholders

• Section Manager: Align SOP, DMR, MPD for production section
• QM Manager: Improve processes for DMR and MPD
• QC/IPQC Manager: Align documentation for production
• Staff Coordinator: Support GMP training documentation and improvement