Unison Pharmaceuticals Pvt. Ltd - Urgent Requirement for B.Sc, B.Pharm, M.Sc, M.Pharm Candidates - Quality Control / Production Departments - PHARMA WISDOM

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Sunday, 13 September 2020

Unison Pharmaceuticals Pvt. Ltd - Urgent Requirement for B.Sc, B.Pharm, M.Sc, M.Pharm Candidates - Quality Control / Production Departments

 

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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2 comments:

  1. Walk-in Drive At Piramal For Production, Quality Control, R&D Operations
    http://www.jobengine20.com/2020/09/walk-in-drive-at-piramal-for-production.html

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