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Our mission At GSK our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. This mission has led us to a world-leading position in developing new medicines, vaccines and consumer healthcare products that are used by millions of people around the world. The challenge of improving healthcare and expanding access to more people is great, and no single organisation can provide all the solutions. Healthcare companies have a role to p... Read More
|Address||150 Beach Road #22-00 Gateway West Singapore 189720|
|Holding||No Holding Details|
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- A diploma in Biotechnology / Chemical Engineering / Life Science or other relevant field
- At least 5 years experience in Biologics / Chemical / Pharmaceutical / Food or other regulated industry
- Good knowledge of cGMP
- Good knowledge of Biologic processes
- Knowledge of purification equipment such as ultrafiltration and chromatography)
- Good communication skills
- Good report writing skills
- Good training skills
- Team player
- Organization and planning abilities
- Problem solving skills
- To supervise the preparation, operation and completion of assigned process stages to ensure the production of bulk drug substances within established timing and quality standards.
- To ensure good housekeeping of the facilities so as to keep them in good operational order in line with cGMP, safety and environmental requirements.
- Supervise a team of technicians and workers to ensure unit performance to fit with unit’s objectives, while adhering to cGMP and safety requirement.
- Ensure good housekeeping of associated production facilities so that they are kept in good operational order.
- Identify areas for improvement and participate in continuous improvement project to enhance operational effectiveness and efficiency of the unit.
- Carries out other related duties as assigned by the N+1Participate in commissioning and qualification activities as required.
- Ensure the smooth operation following the day to day planning
- Assist N+1 in conducting formal and on-the-job training of the team.
- Ensure that he is trained in accordance to the training matrix so as to perform the job and follows cGMP
- Participate in deviation investigation process ( Process, Environmental, Maintenance/Equipment, QC) and coordinate the implementation of Corrective and Preventive Action.Participate in cGMP self-inspections to ensure compliance with internal and regulatory requirements
- Operate and fill in computer application related to production function and management to allow completion of SAP transactions.
- Ensure that batch record, check-list and logbooks are correctly recorded, cGMP complied and maintained to facilitate process order settlement.
- Maintains clear communications with N+1 and technicians and ensure clear feedback of any items pertaining to safety, quality and efficiency.
- Participation in development and generation of production check-list, SOPs, validation protocols and the regular review and updates of these documents.
- Participate to new technology and/or new process transfer Security / Safety / Environment
- Ensure safe and secure operations in the unit.
- Inspects and housekeep assigned production areas, equipment and materials
- Identify and report all potential safety issues ( personal protection requirement, equipment protection, way of working etc )Interface with other Department/Team
- Regular meeting and discussion with direct collegue to resolve issues (e.g. timely supplies of materials and buffers, process issues,…
- Regular discussion with QA, QC, maintenance and calibration team to ensure smooth production operation
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