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.
