Specialist-Production

KEY DUTIES AND RESPONSIBILITES:

. Support the establishment of new production plants including cream, nasal spray, prefilled syringe and pilot plant.

. Take part in FAT of new machines and equipment.

. Participate in Engineering Batch and Registration Batch for new products.

. Perform all activities in accordance with cGMP.

. Responsible for providing guidance and training for assigned employees.

. To lead production team after the start of new product commercialization.

. Develop and implement operational procedure regarding general practice, machine operation, equipment handling in form of SOP Batch Manufacturing/Packaging Record as well as manufacturing instruction for new plant.

. Troubleshoot and optimize production processes to ensure smooth and efficient operations.

. Be involved in equipment / process qualification.

. Assist in investigation of process deviation, cGMP and all other compliance related matters, where applicable.

. Ensure compliance to GxP / Safety / Quality policies.

. Undertake any other duties assigned by manager.

REQUIREMENTS:

. Strong understanding of safe working practices and cGMP.

. Possess extensive hands-on experience and knowledge in pharmaceutical manufacturing processes.

. Good mechanical aptitude with the ability to provide technical guidance

. Prior experience in FAT and Engineering Batch is a plus.

. Demonstrate strong analytical and problem-solving abilities to optimize processes and implement effective solutions.

. Excellent attention to detail and ability to multitask.

. Good written and verbal communication

. Willing to work in Tuas area, in cleanroom environment with full gowning.

. Able to commit to rotational shift.

EDUCATION & EXPERIENCE:

. Bachelor's degree in Science /Mechanical Engineering/Mechatronics Engineering or relevant disciplines

. With 3-5 years of manufacturing experience in Pharmaceutical or related industries.