Title:  Operator

Job description & responsibility:

• Sets up, runs, and Cleans equipment in Production Area and makes product following appropriate procedures in a clean and safe work environment meeting with all cGMP, JFDA, and other applicable regulations.
• the Production Operator is responsible for the finished drug product. The Production Operator position will execute these tasks manually or will be responsible for operating equipment that performs these functions.
• Sets up, maintains, and operates various pieces of computerized Production equipment.
• Sets up, maintains, and operates compression & coating machines.
• Performs line clearance of assigned Production lines as required.
• Performs visual inspection of drug product in accordance with SOP’s and cGMP’s.
• Maintains and ensures documentation, both written and electronic, is accurate, complete and factual as required by policies, procedures and regulatory guidelines.
• Completes and maintains applicable logbook and batch record paperwork as required.
• Provides input and suggestions for process improvements as well as for procedure writing and revision.
• Reports machines and manual deviations to area supervisor
• All other duties as assigned.

Qualification

• Diploma in Pharmacy or engineering or any equivalent major

• 0-3 years of Experience in Compression & Coating and/or Granulation process
• Ability to use computers to perform a variety of data-entry transactions and to retrieve information (procedures; safety, employment, and other information). Must be proficient in MS Office products (specifically Word, Outlook, and Excel).
• Ability to perform data entry/maintenance in SAP or equivalent systems.
• Good English language skills (especially in reading and writing) is required.
• Pharmaceutical or other regulatory (GMP) experience is preferred.
• Employee may be required to stand continually throughout the shift.
• Employee may be required to attend on morning or night shift with long shift is required.
• Employee may be required to attend weekend.
• Job involves frequent bending, twisting, pushing, pulling and lifting.