Process Technician, Production

Process Technician, Production

Location : Negeri Sembilan (Bandar Baru Enstek)

Salary : 6000 - 7999

Key Responsibilities :

The Process Technician, Production will be handling few critical equipment with 21 CFR Part 11 compliance namely Granulation Suites, Fluid Bed Processor (Drying, Top Spray and Wurster Bottom Spray process), Roller Compactor (Dry Granulation process), Compression (in specific Fette 3030P and/or Bilayer Tablet Compress process), Coating, Encapsulation, Blister Packing, Bottle Packing and Serialisation machine in USFDA - GMP plant environment. The candidate must be well-experienced in the GMP Pharmaceutical Oral Solid Dosage ecosystem and have a strong credential in completing tasks as per schedule, meeting target throughput, and desired product quality. He or she shall have experience in facing international audits, preferably in USFDA, and be able to deliver at compliance state of the equipment at all time. The incumbent will be responsible for direct reports (team of executives and Manager) who will be the conduit for product development cycles, process improvements and overall operational excellence within the production work of scope.

Key Responsibilities: -

• Responsible to perform daily production activities in the plant in compliance with current Good Manufacturing Practice (cGMP), regulatory mandates and quality requirements.

• Responsible to prepare and arrange tasks for the Manufacturing Lines and Packing Lines.

• Responsible to handle recipe management, operate and perform troubleshooting for the equipment in Manufacturing Lines and Packing Lines in safe and efficient manner.

• Responsible to execute manufacturing and packing process, performing required in-process product quality checks, cleaning of equipment, ancillary equipment, change part and facilities, tablet compression tooling and packing change part management and performing line clearance for product/ batch changeovers.

• Responsible to operate other Production's equipment or provide assistant as assigned by superior.

• Responsible to check and fill-in batch record, logbook, and other documentations with GMP environment.

• Responsible to assist with on-the-job training of other production trainees and operators.

• Establishes and maintains effective communication with production and cross-functional team.

• Responsible to follow safety guidelines at the workplace.

Requirements

• Must possess minimum Technical Certificates in Science, Pharmacy, Pharmaceutical, Engineering or equivalent.

• Minimum 5 years related experience from Pharma OSD, industry.

• Experience in working with OSD and knowledge on other dosage forms shall be an advantage.

• Strong technical skills in Blending, Granulation, Compression, Coating, Encapsulation and/or Packing.