Current Responsibilities
Supervise all Quality Assurance activities.
Ensure implementation of QA and cGMP activities.
Perform / Supervise and Assist Quality Assurance activities based on Quality System Elements through change control, deviations, documentation, calibration and maintenance of Q.A equipments, implementation of CAPA, Quality Risk Management, stability, validation, audit, training etc.
Perform and Supervise all ISO 9001 2015 (QMS).
To coordinate with Procurement Department / QCD Department in conducting supplier audit / inspection and maintain all records accordingly.
Self Inspection.
To review new vendor data before approval.
To conduct vendor evaluation.
Maintain GLP, GMP and other ethical practices in Q.A department.
Preparation and revision of SOPs for Q.A.
Revision of SOPs prepared by other departments.
Preparation and revision of all other related documents like BPR, BMR, and other formats etc, if required.
Assist and coordinate the inspection of the plant and prepare the reports accordingly.
Preparation, Issuance and implementation of Validation Master Plan. Preparation and Issuance of Process and Cleaning Validation Protocols.
Coordinate with production in conducting Process and Cleaning Validations of different products.
Coordinate with production in conducting validation / qualification (DQ, IQ, OQ, PQ) of production equipments / instruments.
Maintain standard of safety and housekeeping in GMP regulated areas.
Provide training to the junior staff, internees etc.
Batch Document Audit. .

Current Responsibilities:Supervise all Quality Assurance activities.
Ensure implementation of QA and cGMP activities.
Perform / Supervise and Assist Quality Assurance activities based on Quality System Elements through change control, deviations, documentation, calibration and maintenance of Q.A equipments, implementation of CAPA, Quality Risk Management, stability, validation, audit, training etc.
Perform and Supervise all ISO 9001: 2015 (QMS), ISO:14001:2015 (EMS) & ISO 45001 (OH&S) activities.
To coordinate with Procurement Department / QCD Department in conducting supplier audit / inspection and maintain all records accordingly.
Self Inspection Audit.
To review new vendor data before approval.
To conduct vendor evaluation.
To conduct Equipment Cleaning HOLD time studies and preparation of Protocol accordingly.
To conduct Dirty Equipment HOLD time studies and preparation of Protocol accordingly.
Designing, implementation & maintaining the Environmental Management system and OHSAS.
Maintain GLP, GMP and other ethical practices in Q.A department.
Preparation and revision of SOPs for Q.A.
Revision of SOPs prepared by other departments.
Preparation and revision of all other related documents like BPR, BMR, and other formats etc, if required.
Assist and coordinate the inspection of the plant and prepare the reports accordingly.
Preparation, Issuance and implementation of Validation Master Plan. Preparation and Issuance of Process and Cleaning Validation Protocols.
Coordinate with production in conducting Process and Cleaning Validations of different products.
Coordinate with production in conducting validation / qualification (DQ, IQ, OQ, PQ) of production equipments / instruments.
Maintain standard of safety and housekeeping in GMP regulated areas.
Provide training to the junior staff, internees etc.
Batch Document Audit. To conduct Equipment Cleaning HOLD time studies and preparation of Protocol accordingly.
To conduct Dirty Equipment HOLD time studies a

Responsibilities:
• Assist Manager Quality Assurance in all Quality Assurance activities.
• Assist Manager Quality Assurance in the implementation of QA and cGMP activities.
• Perform / Supervise and Assist Quality Assurance activities based on Quality System Elements
through change control, deviations, documentation, calibration and maintenance of Q.A
equipments, implementation of CAPA, Risk Assessment, stability, validation, audit, training
etc.
• Assist Manager Quality Assurance in all ISO 9001: 2015 activities.
• Maintain GLP, GMP and other ethical practices in Q.A department.
• Perform/ Coordinate and supervise the different activities of quality assurance department
• Preparation and revision of SOPs for Q.A.
• Revision of SOPs prepared by other departments.
• Preparation and revision of all other related documents like BPR, BMR, and other formats etc,
if required.
• Assist and coordinate the inspection of the plant and prepare the reports accordingly.
• Preparation, Issuance and implementation of Validation Master Plan.
• Preparation and Issuance of Process and Cleaning Validation Protocols.
• Coordinate with production in conducting Process and Cleaning Validations of different
products.
• Coordinate with production in conducting validation / qualification (DQ, IQ, OQ, PQ) of
production equipments / instruments.
• Maintain standard of safety and housekeeping in GMP regulated areas.
• Provide training to the junior staff, internees etc.
• Attends any other job assigned or delegated by the Manager Quality Assurance.
• Batch Document Audit.
• Cleaning and Process Validation of different products.

• Assist DM Quality Assurance in various Quality Assurance activities.
• Perform / Supervise Quality Assurance activities based on Quality System Elements through change control, deviations, documentation, calibration and maintenance of Q.A equipments, stability, validation, audit, training etc.
• Maintain GLP, GMP and other ethical practices in Q.A department.
• Perform/ Coordinate and supervise the working of the Quality Assurance department.
• Prepare and review SOPs for Q.A.
• Review SOPs prepared by other departments.
• Assist and coordinate the inspection of the plant and prepare the reports accordingly.
• Issuance of protocol for validation.
• Coordinate with production in conducting validation / qualification (IQ, OQ, PQ) of production equipments / instruments.
• Submit a monthly report of quality assurance activities to the manager Q.O.
• Provide training to the junior staff, internees, etc.
• Assist DM Quality Assurance in routine Quality Operations activities and issuance of reports.
• Attends any other job assigned or delegated by the DM Quality Assurance.
• Preparation of Annual Product Review reports for different products.

Besides that Supervise & Perform In process controls at:

• Tablet manufacturing, compression, and coating, blistering and packing.
• Capsule manufacturing, filling, polishing and packing.
• Liquid manufacturing, filling and packing.
• Granules manufacturing, filling and packing.
• Lozenges manufacturing, blistering and packing.
• Dispensing of raw materials.
• Approval of overprinting issues.
• Maintain standard of safety and housekeeping in GMP regulated areas.
• Checking of issuance of Finishing/Packaging Commodities.
• Finished Goods releases.
• Sampling of bulk and finished products.
• Preparation and updating in process specifications of the products.
• Analysis and inspection of all packaging material and updated record keeping on ERP system.
• Line clearances and in processes through SAP

In process controls at:

• Tablet manufacturing, compression, coating, blistering and packing.
• Liquid manufacturing, filling and packing.
• Lozenges manufacturing, blistering and packing.
• Dispensing of raw materials.
• Approval of overprinting issues.
• Maintain standard of safety and housekeeping in GMP regulated areas.
• Checking of issuance of Finishing / Packaging Commodities.
• Perform Batch Document Audit.