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