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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:2 days ago| Platform: Shine logo

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Skills Required

capa data integrity quality systems system implementation audit compliance approvals preventive maintenance equipment qualification sop preparation qms documentation cc investigations edms documents study protocols qualification protocols engineering maintenance gmp compliance ehs requirements health safety measures good manufacturing practices reviewing documents validation activities equipment pm utilities maintenance equipment breakdowns maintaining critical spares good communication skills dedication enthusiasm motivation persuasive ability working in a team working in a crossfunctional environment meeting tight deadlines prioritizing workloads developing new ideas creative solutions

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: 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. Key Responsibilities: - Handling QMS documentations like CC, CAPA, and Investigations - Managing EDMS documents, study protocols, and qualification protocols - Performing activities related to Engineering & maintenance at Biologics Unit 03 - Ensuring GMP compliance and error-free operations - Following all EHS requirements at the workplace to ensure individual and plant safety - Completing all assigned mandatory trainings related to data integrity, health, and safety measures on time - Ensuring compliance to quality systems and current good manufacturing practices - Developing procedures and practices that promote safety operations compliant with company and regulatory norms - Adhering to Standard Operating Procedures and safety requirements Qualifications Required: - Bachelor of Engineering degree - 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 - Performing preventive maintenance, equipment qualification, validation activities, equipment PM, utilities maintenance, SOP preparation, attending equipment breakdowns, maintaining critical spares, and more Additional Company Information: Syngene International Ltd. is an equal opportunity employer dedicated to providing integrated scientific services to various industries globally.,

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QMS Incharge