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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Manufacturing |
| Functional Area | General / Operations Management |
| EmploymentType | Full-time |
Supports the Process/equipment validation and participates in yearly validation review to the site. Interfacing as appropriate with Development, Quality, Manufacturing, Purchasing and Suppliers, the incumbent assists and provides technical support for internal and external suppliers. Ensures process documents are created, updated and in compliance with company standards, ISO and GMP as required.Boundary Conditions/Authority Levels: Receives instruction on routine work, instructions on new assignmentEssential Duties and Responsibilities:Include the following. Other duties may be assigned.Equipment Commissioning & Qualification documentation associated to Manufacturing, Process, and Utility.Preparation & Execution of SAT, IQ, OQ, PQ Protocols of process equipment s, Utilities and Clean room facilities.Preparation of Risk documents and participate in Risk Assessments.Implementation of systems such Periodic review & periodic requalification to support cGMP compliance.Developing quality standards documents for validation and approval of protocols, reports.Periodic review & periodic requalification to support cGMP compliance.Exposure to international regulatory authority audits (e.g. UFDA & WHO) and requirement of ISO 13485/9001 standards.Enhancement of systems and procedures.Ensuring compliance to systems and procedures.Should have experience in working with cGMP Industry.Perform tasks individually and display a Troubleshooting skill.Education and/or Experience:Bachelor s degree in field with 5-6 years exp. OR Master s degree in field with 2-4 years experience.Candidate with qualification of BSC/ MSC or BE in biotechnology/Biochemistry, .
Keyskills :
qualitystandards processequipment oq pq gmp iso sat risk cgmp equipment protocols utilities suppliers echnicalsupp