Quality Assurance-pharmacist

Job Responsibilities :

1.Preparation, Revision & Training of QA SOPs:

• Hands on Experience of SOP Management

• Preparation & Revision of QA SOPs in Control Document Management System (CDMS) as per requirement.

• To conduct Training of approved QA Sops 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 CAPAs in Track-wise system after agreement with stakeholders.

• Verification of CAPAs 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 CAPAs.

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

• Raise and progress departmental change controls, deviations and CAPAs.

Job Type: Full-time

1. Excellent written and verbal English Communication skills 2. Accountable to perform tasks on- time and with accuracy. 3. Strong team players with ability to work independently and in a team.