Unison Pharmaceuticals Pvt Ltd Job Opening For BSc/ MSc/ M.Pharm/ B.Pharm - Production - Documentation/ Production - Compression

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