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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