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Biological E
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Executive / Senior Executive For Corporate Quality

Executive / Senior Executive For Corporate Quality

Biological E

4 - 9 years

4 - 9 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

Internal Audit USFDA Sterile Vender Qualification Injectables 21CFR

Work Mode

Work from Office

Job Type

Full Time

Job Description

Handling of all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. To perform On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing, external service vendors qualifications. Initiation and Review of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs. To perform Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities. Preparation & review of Quality agreements & Technical agreements. To provide support / relevant information to the customers / suppliers as per the requirement and to provide remediation plans for the audit observations, if any To schedule, perform the self-inspections and review the Self-Inspection reports and relevant documents as applicable. To facilitate and review the performance of quality system through the review of QMS documents for Management Review Meetings. To co-ordinate for Management Review Meetings. To review and monitor the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks. To track the health authorities observations at the Site and R&D and verify the compliance. To coordinate with the team for preparation and implementation of SOPs pertaining to Corporate Quality.

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