Quality Assurance Executive

Responsibility of managing documents related to process development, Scale up and manufacturing of recombinant proteins and extraction of proteins.
Verification of day-to-day production activities to ensure proper documentation during production.
Handling of QMS Issues related to production as appropriate to the timely completion of management objectives.
Preparation of SOPs, BMRs, Protocols and other documents needful to comply GMP aspects in manufacturing area.
In process quality Assurance checks during batch processing.
Verification of concurrent updating of batch related documents and logbooks in Mfg.
processing area.
To Review Final BMRs to ensure adequate documentation and compilation of datas.
Responsible to complete and verify production and QA activity require to achieving timely completion of production activity along with dispatch of the final products and to provide Guidance to production related to good Documentation Practices.
To verify time being completion of Quality control checks and analysis related to manufacturing activities.
Assure Recording and Monitoring of Environmental Monitoring parameters (Temperature, Differential/Absolute pressure, Relative humidity and non-viable particle Count).
Verification of Compliance of the area and equipments as per GMP.
Verify time to time preventive maintenance and schedule of preventive maintenance of the Equipments.
Handling Quality management system (Incident, Deviation, change control and CAPA).
Involvement in IQ, OQ and PQ of new equipments as well as involvement in cleaning validation activity along with compilation of data of same.
To fulfill responsibility as QA whenever needful and complete the Role as QA for all department whenever required.
Any other work assigned by HOD.
Required Skills.
Ability to work and liaise with cross-functional teams.
Ability to handle auditors.
Experience in cGMP facility, GDP & Audits.
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