Job Description
Description:
- Responsible for Preparation and Implementation of SOP's.
- Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
- Responsible for personnel monitoring.
- Responsible to participate in qualification, requalification, area qualification activities
- To prepare Cleaning Validation Matrix, assessment of worse case products, cleaning validation protocol and reports, investigation of cleaning validation failures, PDE report review and assessment and all relevant task related to cleaning validation.
- Responsible for Compilation and review of Annual product quality review (APQR) report and schedule.
- Activities other than that defined in the job responsibility are to be done, as per the requirements /instruction / guidance of HOD.
- Responsible to handle Quality Management Documents like Change Control, Deviation etc.
- Responsible for logging and closure of the change control related to document, equipment/instrument,facility /utility, process/product etc.
Education:
- B. Pharm B. Pharm - Required
- Master Degree (MS/MA) M.Sc. - Preferred
Experience:
- 8 years or more in 8 - 10 Years
Specialized Knowledge: Licenses: