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MES consultant For CSV Validation

5 - 8 years

10 - 15 Lacs

Bengaluru

Posted:-1 days ago| Platform: Naukri logo

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Skills Required

Training Computer system validation Leadership development Quality standards Compliance IT infrastructure Author Management Operations Testing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Overview As an Life science professional you will be part of the Global Business development team who will be responsible for driving LSC activities in Expleo India. Expleo is the home of bold and reliable minds. With more than 50 years of experience in developing complex products, optimizing manufacturing processes, and ensuring the quality of information systems, Expleo boasts an extensive global footprint, powered by 19,000 highly skilled experts delivering value in 30 countries. Our efforts in creating a supportive and inclusive workplace in India have earned us some key recognitions: Great Place to Work certification for building a supportive, engaging environment. Progressive Place to Work, by ET Now, for our dedication to innovation and inclusive workplace policies. Best Organizations for Women, by ET Now, for empowering women by providing equal opportunities, supporting professional development and promoting inclusive leadership. Responsibilities The MES CSV Consultant will be responsible for the Computer System Validation (CSV) activities related to Manufacturing Execution Systems (MES). This role involves ensuring compliance with regulatory requirements and company standards, executing qualification activities, and supporting the implementation and validation of MES applications. Qualifications Bachelors degree in IT, Engineering, or a related field. Proven experience in MES and CSV activities within a regulated environment. Strong understanding of regulatory requirements and industry standards for CSV. Excellent documentation and communication skills. Ability to work collaboratively with cross-functional teams. Essential skills IT Infra Qualification Activities: Conduct qualification activities for IT infrastructure related to MES projects. Ensure compliance with regulatory requirements and company standards. MES Application CSV Deliverables: Manage CSV deliverables from Factory Acceptance Testing (FAT) to Operational Qualification (OQ). Execute qualification activities in the eCSV application. Validation and Compliance: Author and review validation plans, specifications, and risk assessments. Maintain end-to-end documentation for all deliverables and instances. Ensure adherence to SOPs and regulatory guidelines during validation activities. eCSV activities : Manage document authoring ,issuance and controlling processes and create associated documentation within eCSV tool. Participate in quality discussions and ensure compliance with quality standards. Training and Support: Provide training and support to end users on MES applications and CSV processes. Collaborate with cross-functional teams to ensure successful implementation and validation of MES projects. Desired skills Experience with eCSV applications and MES systems.( PASX) Knowledge of GxP and ERES assessments. Familiarity with IT infra qualification and validation processes. Experience 1- to 4 Years and 5 to 8 Years, Benefits Collaborative working environment \u2013 We stand shoulder to shoulder with our clients and our peers, developing solutions that create a sustainable today and tomorrow. Continuous learning - Our Learning & Leadership Development team has established a world-class learning ecosystem that enables you to acquire and develop the right skills by delivering a suite of accredited training courses. Global organisation - We provide solutions to leading brands from various sectors, giving you the opportunity to work with top-tier companies providing impactful solutions to our customers\u2019 customers.

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Saint Quentin en Yvelines Ile-de-France

10001 Employees

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