Quality Assurance

Role & responsibilities

RESPONSIBILITIES: -

To follow the cGMP Rules and regulation.

Documentation Control: maintenance, updation and issuance of documents in compliance with regulatory requirements and implementation of Good Documentation Practices.

Review and approval of all Master documents like SOP, Batch Manufacturing record, Batch packing record, Calibration schedule, Preventive maintenance Schedule and other quality related documents

Responsible for preparation and review of protocol and report for Process validation, Cleaning validation as per the schedule and validation master plan.

Handling of documents like SOPs, formats / Annexures, Log Books, BMR / BPR & all other GMP Documents like Change control, deviation, incident, CAPA, breakdown slips etc

Responsible for preparation, review and approval of DQ, IQ, OQ and PQ documents for new equipment or existing equipment

Responsible for handling of change controls & implementation of changes.

Responsible for review of all batch related documentation, to support Quality Head to release the product, to support and maintain Environmental Health and Safety requirements as applicable.

To perform & review of risk assessments.

Review & signing of Finished Product data & Certificate of Analysis & product release certificate.

Responsible for review & signing of product stability data

Responsible for preparation/execution of Self Inspection.

Responsible for Annual product quality review reports.

Responsible for handling & maintenance of control / retain samples.

Responsible for review & updation of Batch Manufacturing / Packing records & its issuance.

Responsible for review, updation & maintenance of Master Formula Records.

To plan and execute employees training about departmental SOPs.

Responsible for review the SOPs of Quality Assurance department.

To review of product stability data, Control and retain sample evaluation record

To review & approve all the specifications & standard testing procedure

Responsible for Implementation & to check effectiveness of all regulatory requirements.

To support regulatory department related to documentation & dossier submission activities and to resolve the received technical queries.

Responsible for review & approval of artworks

To review & approve shade cards.

Responsible for review & approval of Bill of Materials.

Execution and review of Aseptic process simulation study

To support IPQA head / team as and when required

To support Validation / Qualification head / team as and when required

To check the effectiveness of GEP (Good engineering practices) at service floor, HVAC system, water system, Nitrogen system and Compressed air system.

Review of APQR

Responsible to inform any Non- Conformity observed in area to Head of the Department

Approve or rejecting starting materials, packing materials, intermediate and bulk roducts in relation to their specifications & batch release.

To prepare/approve risk assessment documents.

To participate in external audit.

Handling of recall.

To approve and monitor analyses carried out under contract.

To ensure maintenance of department, premises and equipment.

To ensure appropriate validations including those of analytical procedures and calibrations of control equipment are carried out.

To ensure training of personnel is carried out.

To approve/authorize personnel of all department.

To approve gowning qualification of personnel.

To ensure/ maintain archival system of documents.

Any assignment other than above responsibility given by reporting authority.

Maintenance of Job responsibilities, Organograms & Specimen signature logs

Preferred candidate profile

Majorly who Have experience in Injectable and Team Handling