Unison Pharmaceuticals Pvt. Ltd - Urgent Requirement for Quality Control / Production Departments Apply Now
Openings @ Unison Pharmaceuticals Pvt. Ltd
Location: Ahmedabad
Opening for Quality Control – GLP
Experience: 2-6 yrs
Roles and Responsibility
- Responsible for handling of instruments like HPLC, Dissolution Test Apparatus, UV Spectro Photometer, Disintegration Apparatus and Other Physico Chemical instruments.
- Responsible for perform the Calibration of all Analytical Instruments/Equipment lying at Quality control laboratory.
- Responsible to perform Equipment/ Instruments Calibration/ Verification. In-case of OOC results inform to superior immediately and follow respective SOP.
- Responsible for maintain the Inventory, log record of HPLC columns as per respective Column management SOP.
- Execution of Calibration and Preventive Maintenance of QC instruments as per predefined schedule.
- Working Standard, Reference Standard and Chemical/Reagent management.
- When require give the support in Analytical document preparation like SOPs , Specification, Method of Analysis , Worksheet , Analytical Method Transfer Protocol and Report.
- To follow Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Safety precautions during routine analytical activities.
- Daily/ weekly monitoring of Temperature/ Humidity of QC laboratory.
- To ensure availability of current version SOPs, Specifications, MOAs, STPs.
- To prepare SOPs, Specifications, MOAs, STPs and other documents.
- Responsible for preparation of Analytical documents like Specification, Method of Analysis and Worksheet for Active Raw Material, Inactive Raw Material, Finished Product, Finished Product Strip/blister, Semi Finished Product, Granules, and Packing Material and for working standard qualification.
- Preparation and maintenance of Miscellaneous documentation.
- Archival and Retrieval of Quality documents.
For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements
Opening for Quality Control – HPLC
Experience: 2-7 yrs
Job Purpose:
The QC analyst performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. He / She conducts and validates various biological and chemical quality control Assay, RS, Dissolution, CU, BU, Swab etc. He / She compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations. He / She is also responsible for establishing specifications for conducting various analyses.
Key Accountabilities/ Responsibilities
1. HPLC Operation (Analyst)- Assay
- Collect worksheet and sample for analysis as per plan
- Check the instrument calibration details
- Purging the interior part of the instrument
- Take the columns as per worksheet and put in instrument
- Initiate solution preparation for analysis as per worksheet which majorly includes; Mobile Phase, Standard and sample
- Prepare HPLC sequence for analysis and get it review by reviewer
- As per the sequence initiate the analysis and online verify SSC criteria as per worksheet
- Post completion of the analysis perform documentation and send to reviewer
- Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range
2. HPLC Operation (Analyst)- Dissolution
- Collect worksheet and sample for analysis as per plan
- Check the instrument calibration details
- Purging the interior part of the instrument
- Take the columns as per worksheet and put in instrument
- Initiate dissolution solution preparation for analysis as per worksheet and also prepare dissolution medium
- Perform dissolution analysis as per the criteria mentioned in worksheet
- Post completion of the analysis perform documentation and send to reviewer
- Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range
3. HPLC Operation (Analyst)- Others
- RM- Assay, RS, IR
- In process- Assay by UV and HPLC
- PV Sample- Assay by UV and HPLC, Dissolution
- FP- Assay, Dissolution, RS, DT, Average weight, hardness, Friability, IR
- Cleaning validation
Opening for Production - Documentation (QMS)
Experience: 3-6 yrs
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
Opening for Production – Compression
Experience: 2-6 yrs
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.
Qualification: B.Sc / B.Pharm / M.Sc / M.Pharm
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
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