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Senior Officer, QA Validation
About the job Senior Officer, QA Validation
Job Title: Senior Officer, QA Validation
Job Location: Ahmedabad, Gujarat, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Job Description
Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification.
Responsible for preparation and review of Validation/ Qualification protocol and report.
Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities.
Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities
Responsible for preparation and review of media fill and hold time protocol and report.
Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc..
Responsible to prepare protocols of process validation and cleaning verification/validation.
Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..)
Qualifications
Qualification - M.Sc. / B. Pharm / M.Pharm
Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification.
Responsible for preparation and review of Validation/ Qualification protocol and report.
Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities.
Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities
Responsible for preparation and review of media fill and hold time protocol and report.
Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc..
Responsible to prepare protocols of process validation and cleaning verification/validation.
Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..)
Qualifications
Qualification - M.Sc. / B. Pharm / M.Pharm
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