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| Unison Pharmaceuticals Pvt Ltd Job Opening For BSc/ MSc/ M.Pharm/ B.Pharm - Production - Documentation/ Production - Compression |
1. Production - Documentation
Education
B.Pharma in Any Specialization, B.Sc in Any Specialization
MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
Experience: 3 - 6 Years
Work Location: Ahmedabad(Moraiya), gujarat
Preferred Key Skills
QMS, Production, Documentation
Other Key Skills
Quality Management System
Job Description
Opening for Production - Documentation (QMS)
Job Purpose
The incumbent plays major role in completing all QMS related activities from production team. The person is responsible for coordinating and implementation of all QMS activities for production.
Key Accountabilities/ Responsibilities
1. Quality and compliance
Change control- Initiation, follow-up, action plan and closing
Deviation- Initiation, investigation, CAPA and action plan
Market complain- Performing investigation related to production, root cause identification, analysis and report preparation
OOS / OOT- Investigation, root cause identification, documentation, CAPA and action plan
SOP- SOP preparation, change / revision, format issuance and control
BMR- Master BMR and executed BMR preparation and review, correction if needed and submission to QA
Process validation - Protocol review and final report review, audit trail review (SCADA) and compliance justification
Preparation and submission of self-inspection compliance report
2. Others deliverables
Job description preparation for new employees joining in production team
Updating SOP master list in a frequency of 3 month or whenever needed
Performing batch entry process tracking and batch transfer in Pharma Cloud
Weekly review formats and log books for various activities like; sieve inspection record, sieve issuance record and FBD bag issuance record
For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
2. Production - Compression
Education
B.Pharma in Any Specialization, B.Sc in Any Specialization, M.Pharma in Any Specialization, MS/M.Sc(Science) in Any Specialization
Experience: 2 - 6 Years
Work Location: Ahmedabad(Moraiya), gujarat
Preferred Key Skills
Compression, Production, Fette
Other Key Skills
Cadmach
Job Description
Opening for Production - Compression
Job Purpose
This position provides front line leadership to direct reports in support of manufacturing of drug products and drives a culture of compliance, ownership and continuous improvement by blending an understanding of lean concepts with a working knowledge of equipment, processes and systems.
Key Accountabilities/ Responsibilities
1. Production and Documentation
Initiate process for taking manufacturing batch as per the schedule shared by Production head
Environment monitoring of the area and filling log book for Temperature RH and Differential pressure.
Inform engineering team and get corrected, if found any discrepancy. Verify rectifications related to discrepancy.
Verify weighing balance
Checking calibration of weighing balance and validity of preventive maintenance
Prepare issuance request for IPA (Iso propyl Alcohol)
Receive material from quarantine area for compression
In process check of tablets as per BMR
Perform metal detector challenge test
Perform IPQC as per frequency in BMR: Uniformity of weight, thickness, hardness, disintegration time and friability
Batch reconciliation and yield calculation
Ensure return riser filter cleaning and area cleaning
Sending compressed tablets in quarantine area and making entry
Ensure changeover activities as per SOP
Give intimation to QA for IPQC sample and Line clearance after changeover completion
2. Quality Excellence
Ensure adherence to SOP, GMP guidelines, BMR during the compression process
Perform all document related activities; BMR filling, Log books, Die punch issuance and uses records etc. as per GDP.
BMR and log book entry in Pharma Cloud
Preparing QC sampling request for QC analysis in Pharma Cloud
Facilitate all applicable SOP trainings to new technicians and helper joining in the area
3. Production Hygiene and Cleanliness
Responsible for maintaining cleanliness and hygiene in the compression area as per the regulatory requirement
4. Machine Operation and Troubleshooting
Responsible for appropriate and efficient use of machine and equipment in the area
Coordinate with engineering team for any machine related troubleshooting and ensure quick resolution to the problem
Ensure area readiness by checking machine calibration, preventive maintenance status and cleanliness
Issue die-punch as per BMR specification and SOP and ensure inspection of die-punches before initiating the compression activity
Ensure calibration validation of Inspection kit and verify food grade oil certificate
5. New machine installation
During new machine installation, support Engineering, QA and Vendor team for Installation Qualification (IQ) and Operation Qualification (OQ)
Perform Performance Qualification (PQ) at the time of new machine installation under the guidance of production head
Taking validation batches as per the guidance of production head
6. Additional responsibilities
Any other responsibility assigned by management
For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
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