Manufacturing Product Development Specialist

To plan, coordinate and monitor the Holding Time Study activities align with production scheduling, Packaging Development activities and coordinate the documentation activities required in MS&T department such as SOP, Bill of material and Regulatory Documents according to the GMP and Halal regulation.

To coordinate and monitor the Holding Time Study activities align with production scheduling including providing the protocol and report of Holding Time Study.

To coordinate, monitor the Packaging Development activities together with other related departments (Production, QC, Procurement, QA) and do coordination with supplier in related with technical points (drawing, sample, etc.)

• To support the artwork design activity performed by RA department
• To plan and manage Bill of Material required by MS&T department
• To provide and coordinate the availability of Master Production Process Control Record (MPPCR)
• To provide and ensure that all SOP related to MS&T Department are completed and align with GMP. Provide periodic review as required.
• To manage all internal training activities of MS&T personel related to the internal SOP.
• To monitor and provide necessary trainings for MS&T Staffs to ensure that they will be able to generate quality document and improve.
• To perform any other activities as guided by the manager in timely manner.

Control and follow up for closing/ completing all CAPA, Deviation, Change Control and other documents related to the quality system requirements.

Implement QEHS policy in the working area.

Qualifications

• Apothecary Program/Pharma Degree from reputable University.
• 3-5 years experience in Technical support, Product Development and Production in pharmaceutical industry.
• Experiences in cGMP ; GLP; pharmaceutical knowledge.
• Good Interpersonal skills.
• Understand English both oral and written, Computer literate.