Employer Active
Job Alert
You will be updated with latest job alerts via emailJob Alert
You will be updated with latest job alerts via emailJob 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
Salary : 15000/- to 30000/- pm.
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.
Full Time