Purpose
This candidate will primarily be responsible for supervision of shop floor activities of Oral Liquid Packing area in shifts with close monitoring of thorough along with quality compliance & efficiency in GMP environment.
Position / Job Title
Officer
Department
Packing
Reporting To
Head of Department (Packing)
Location
Satara
Years Of Experience
3 6 years
Dosage Form
Oral Liquid
Job Responsibilities / Deliverables
- Ensures compliance of all packing process in accordance with Standard Operating procedures and cGMP and Safety.
- Coordinates for issuance of dispensed material. Ensures execution of schedules (including changeover, line start up and operations) as per standard time.
- Checks and maintains daily performance and all related BPRs are properly recorded as per procedures. Ensure reconciliation and rejections are done and properly recorded as per Standard Operating procedures. To monitor in-process control checks and record in BPR.
- Ensures start up and operations of serialization and aggregation system (includes batch creation, batch number download, operations & batch closure)
- Ensures that operators handle equipment's and instruments safely
- Ensures execution of packing validations for new packs and products.
- To give daily production report and submit completed BPR to Department Head. To check calibration of balances/instruments and preventive maintenance of equipment's. Reporting of the incidence, handling of the deviation and change control whenever required.
- Ensures new machine qualifications are carried out as per standard procedures.
- Performs tasks assigned by managers. Provide ideas for process/machine improvements.
- Verify Calibration, PM, cleaning and usage entries in electronic log.
Qualifications & Pre-Requisites
- B Pharmacy / M Pharmacy / MSC
- Knowledge of Oral Liquid Formulation.
Skills Required
- Should have working knowledge and exposure of all packing equipment's of Oral Liquid Packing or Injectable Packing.
- Total experience of 3 - 6 years in Supervision of Packing Machine.
- Knowledge of safe acts and behaviours and compliance to safety
- Exposure of regulatory audits -USFDA, MHRA, TGA, ANVISA etc
- Use of SAP systems
- Command on operations & manpower in packing lines.
- Operation of serialization equipment's
- Exposure to digital platforms such as electronic log, QMS and DMS etc.
Additional Notes
- Role is expected to work in all shifts.
