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QMS incharge

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Syngene International Limited

9 - 13 years

0 Lacs

karnataka

Posted:1 week ago| Platform: Shine logo

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Skills Required

preventive maintenance equipment qualification sap handling qms documentation handling of edms documents ensuring system implementation ensuring audit compliance reviewing of documents approvals validation activities preparing master list planners coordinating with vendors monitoring utilities preparing sops attending equipment breakdowns identifying critical spares reconciliation archival of documents providing trainings monitoring hvac parameters qms closure client regulatory audits preparation of quality department protocols support for vendor qualification maintaining layouts completing inhouse modificat

Work Mode

On-site

Job Type

Full Time

Job Description

As a Deputy Manager at Syngene International Ltd., your main responsibility will be handling QMS documentations like CC, CAPA, and Investigations, as well as managing EDMS documents, study protocols, and qualification protocols. You will be in charge of performing activities related to Engineering & maintenance at Biologics Unit 03 while ensuring GMP compliance and error-free operations. It will be crucial for you to follow all EHS requirements at the workplace to ensure individual and plant safety. Your role will involve completing all assigned mandatory trainings related to data integrity, health, and safety measures on time, and ensuring compliance to quality systems and current good manufacturing practices. You will play a key part in developing procedures and practices that promote safety operations compliant with company and regulatory norms, as well as adhering to Standard Operating Procedures and safety requirements. In terms of educational qualification, a Bachelor of Engineering degree is required for this position. You should have 9-12 years of experience in a relevant regulated environment. Technical skills such as handling QMS documentation, EDMS documents, system implementation, audit compliance, reviewing documents, and approvals will be essential for this role. Additionally, you will be responsible for performing preventive maintenance, equipment qualification, validation activities, equipment PM, utilities maintenance, SOP preparation, attending equipment breakdowns, maintaining critical spares, and more. Your behavioral skills should include good communication skills, both verbal and written, a high level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment. You should be able to work successfully in a dynamic, ambiguous environment, meet tight deadlines, prioritize workloads, and develop new ideas and creative solutions. Syngene International Ltd. is an equal opportunity employer dedicated to providing integrated scientific services to various industries globally.,

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