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
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