Quality Assurance-pharmacist Jobs in Mumbai - GNH India Pharmaceutical Limited

1. Preparation, Revision & Training of QA SOP's:

• Hands on Experience of SOP Management

• Preparation & Revision of QA SOP's in Control Document Management System (CDM'S) as per requirement.

• To conduct Training of approved QA Sop's to all concerned persons.

2. Audit & Inspection Readiness:

• Preparation of Annual Internal Audits schedule.

• Performing Internal Audits as per approved schedule.

• Preparation of Internal Audits report.

• Raised the CAPA's in Track-wise system after agreement with stakeholders.

• Verification of CAPA's effectiveness

• after predefined period.

3. Periodic Product Review:

• Preparation of Periodic Product Review (PPR) of the products.

4. Preparation of Periodic Product Review (PPR) of the products.

• To support contract manufacturing sites for validations during product transfer.

5. Process, Equipment, Facility & Utility Qualification:

• To permed change control assessment validation / qualification perspectives.

• Preparation and Maintenance of Site Validation Master Plan (SVMP).

• Preparation of Monthly presentation on Site validation Steering Committee.

• Tracking of monthly re qualification schedule.

6.Cleaning Validation:

• Preparation of Cleaning Validation Protocols & Reports.

• Performing Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) Study.

7. Quality Management Systems:

To carry out the gap analysis against Quality Management Systems.

• Handling change controls , deviations and CAPA's.

• Carry out risk assessment in view of change in process / introduction of new product.

• Raise and progress departmental change controls, deviations and CAPA's

Job Type: Full-time