Job Overview
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Date PostedAugust 4, 2023
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Location (State / UT)
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Expiration dateJuly 11, 2025
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Experience3 Years, 8 Years
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GenderAny
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Desired QualificationBachelor Degree
Job Description
Quality Assurance Executive/Officer (Sterile/ Injection/ Parentals) IPQA Sterile
- Preparation, execution, compilation & review of Qualification re-qualification protocols.
- Handling of master documents & Issuance of controlled documents i.e. Qualification/ re-qualification Documents, Cleaning Validation documents, Hold time study of drug products
- Checking & Execution of documents/ activities i.e., URS, DQ, FAT & SAT, Installation & operational qualification, Performance Qualification/ re-qualification for equipment, utility, Facility, etc.
- Planning and organizing for cleaning validation/ Hold time study activities of Drug Products: Protocol Preparation, Sampling, coordinating the validation activities, Data compilation
- Coordination with Production, R&D & Q.C. departments for cleaning validation and hold time study.
- Documents review received from Quality Control, R&D, and ADL Department.
- Protocol/ Report Preparation, Review of Temperature mapping activity.
- Review of Re-qualification schedule and monitoring.
- Review of Layouts/ Drawing.
- Preparation of SMF & VMP.
- Involved and reviewed Risk analysis.
- Coordination/ Review of Change controls/ Deviation related activity.
Qualification- B.Pharma/ M.Pharma