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Syngene International Limited
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Commissioning & qualification and QMS

Commissioning & qualification and QMS

Syngene International Limited

5 - 9 years

0 Lacs

karnataka

Posted:1 week ago| Platform: Shine logo

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Skills Required

urs dq iq oq alarm management root cause analysis capa internal audit risk management standard operating procedures validation of computerized systems commissioning qualification validation activities pq protocols calibration program preventive maintenance program maintenance calibration program alarm management system investigation for equipment failure large small capital projects facility walkthroughs data integrity assessment change controls training on sops operational excellence initiatives compliance metrics

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Senior Executive at Syngene International Ltd. in Bangalore, you will be responsible for performing validation of computerized systems for biopharmaceutical manufacturing facilities, as well as commissioning & qualification and validation activities for these facilities. Your role will involve coordinating the Calibration Program, Preventive Maintenance Program, and Alarm Management for the biopharmaceutical manufacturing facilities. You will also be responsible for participating in capital projects, conducting facility walkthroughs and audits, and implementing risk management strategies. Additionally, you will support the preparation and implementation of Standard Operating Procedures, Change Controls, and training activities. Key Responsibilities: - Perform validation of computerized systems for biopharmaceutical manufacturing facilities - Conduct commissioning & qualification and validation activities for biopharmaceutical manufacturing facilities - Coordinate the Calibration Program, Preventive Maintenance Program, and Alarm Management - Participate in capital projects and engineering design - Conduct facility walkthroughs, internal audits, and risk management activities - Support the preparation and implementation of Standard Operating Procedures, Change Controls, and training Qualifications Required: - Bachelor's degree in a relevant field - Minimum of 5 years of experience in validation and qualification activities for biopharmaceutical manufacturing facilities - Strong knowledge of regulatory requirements and quality standards - Excellent communication and coordination skills - Ability to work effectively in a team and independently Please visit [Syngene International Ltd.](https://syngeneintl.com/) to learn more about the company and its operations.,

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Commissioning & qualification and QMS