Virchow Biotech Pvt Ltd Job Vacancy For Quality Assurance Department
●Department: Quality Assurance
●Qualification: Any PG in life sciences or Pharmacy
●Experience: 3 to 8 years
●Designation: Executive to Asst Manager
●No of Vacancies: 5
●Budget: 3.6 to 9 Ipa
●JOB DESCRIPTION:-
1) Responsible for Review and Approval of URS, SAT, IQ, OQ, PQ protocols and reports.
2) Responsible for Equipment Qualifications like Autoclave, vial washing, Tunnel, Mixing vessel, filling machines and lyophilizes etc.
3) Responsible for Utility Qualifications like water system, HVAC system, pure steam, compressed air and Nitrogen gases etc.
4) Responsible for Computer system validations for Process Equipment's and Utilities.
5) Review and Approval of Computer system validation reports of HLRA,Tracebility matrix, periodic review and IQ,OQ and PQ.
6) Responsible for Facility/Area qualifications for sterile Block.
7) Review and Approval of Process/Cleaning Validation, Hold time study Protocols & reports.
8) Responsible for handling media fill activities and smoke studies
9) Review and Approval of Validation master plan (VMP), Site Master File (SMF) and validation schedule for each calendar year.
10)Responsible for internal and external audits and compliance for the same.
11) Training to shop floor team Regarding Validation Activity.
12) Review of the Process Non-conformances (PNC), Exceptions, change control, CAPAS, QRM and Investigations of the cross-functional teams in QMS Module.
13) Review and approval of APQR & proposing recommendations
14) Review and Approval of Calibration and PM Schedules, and calibration of measuring and master instrument reports.
15) Overall responsibility of Qualification and Validation activities to maintain the plant in validated state.
16) Support QA head in ensuring achieving function's goals
●Interested candidates can share with the below mentioned mail-Id:-
Regards,
P.Raghurami Reddy
Sr Manager HR
Virchow Biotech Pvt Ltd
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