Document Control jobs in Malaysia

Biocon is a global biopharmaceutical company transforming patients’ lives in over 120 countries. Guided by our vision to deliver affordable, innovative healthcare solutions, we develop treatments for diabetes, cancer, and autoimmune diseases. At Biocon, we value integrity, innovation, and inclusion, fostering a culture that empowers our people to make a meaningful impact on global health.

Responsible for leading pilot-scale operations, coordinating cross-functional teams, and supporting technology transfer from R&D to manufacturing. Drives experimental studies, data-driven investigations, and process improvements using statistical tools. Drafts and reviews CPV protocols and reports to ensure ongoing process control. Ensures compliance with GMP, EHS, and documentation standards while fostering team development and performance.

• Coordinate the pilot scale planning & execution, equipment and infrastructure maintenance.
• Coordinate within the team, inter-functional and inter-departmental activities for successful completion.
• Support technology transfer activity from R&D to manufacturing including drafting technology transfer documents and coordinate/participate in CFT discussions.
• Perform, plan and coordinate experimental studies as part of investigation and troubleshooting to support manufacturing operations.
• Involve in people management to perform the tasks through effective planning, guiding and review activities for completion.
• Identify opportunities for personnel and team development to realise efficient performance of the team through training and development activities.
• Influential in conflict management within team, if any and effective utilisation of resource.
• Improve performance of team and training identification for team continuously to achieve targets.
• Gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
• Employees who are involved in GMP activities should undergo a mandatory cGMP training.
• Ensure that all mandatory basic training is completed once in a year.
• To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
• Ensure adherence of safe work practices in R&D and interface with EHS team for respective meetings, training, addresals, implementation and compliance.
• Facilitate and address EHS internal & external audit requirements.
• Systemize and Manage biowaste and schedule waste in R&D.
• Ensure compliance and document control for Safety related activities.
• Identify required EHS training need for the R&D employees and ensure compliance.
• Manage proper chemical handling and storage in R&D.

• Ph.D. in a relevant scientific discipline (e.g., Biotechnology, Chemistry, Life Sciences, Pharmaceutical Sciences)
• Master’s degree in a relevant field with relevant industry experience (e.g., process development, technology transfer, manufacturing support)
• Strong knowledge of GMP, technology transfer, data analysis, and cross-functional coordination

At Biocon, you’ll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym/sports room, and exceptional opportunities for career advancement.

Be part of a global biopharma pioneer making a real impact on healthcare worldwide.