CSV Engineer

Posted 03 Jun 2019

Nantong, Jiangsu - China

Req Id 192993

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Your role:

Overall Objectives of the Position

This role will lead site computerized system validation (CSV) and maintain that CSV activities consistently complies with all regulatory and corporate requirements in support of regulatory (Chinese GMP, EU GMP, ISO and applicable agencies) and customer expectations.  This position will also entail validation Management system buildup and maintenance, to ensure the system compliance with all Domestic and Global regulatory and corporate requirements.

Main Tasks

•     Establish local procedure for computerized system validation (CSV) lifecycle management (i.e. risk assessment, validation planning, execution and reporting, post-validation status maintenance, de-commissioning), and ensure that local management procedure complies with GxP validation regulatory requirements.

•     Write VMP, Validation Plans and protocols for Computerized Systems, e.g., SAP, ERP, PAS and etc, in collaboration with Subject Matter Experts, ensure validation documents comply with regulatory requirement, life science global and local quality standards

•     Lead CSV risk assessment to identify validation scope and extent, ensure CSV work is well organized and CSV requirements are fulfilled.

•     Coordinate URS creation, lead and supervise DQ/FAT/SAT/IQ/OQ/PQ&UAT execution including test execution witness and result review.

•     Review and approve Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors. Supervising contractors performing commissioning and qualification activities.

•     Specify, select, and coordinate purchase of testing equipment and associated consumables used in execution of qualification Protocols.

•     Review Validation Deviations and managing their closure by the agreed dates.

•     Review validation report, prepare and approve validation summary reports.

•     Lead Post-CSV validation status maintenance including system register updating, configuration management, security management, audit trail review, ERES, service level agreement, backup and recovery, data Retention, Archiving and Retrieval, business continuity planning, periodic validation status review and etc, manage site CSV compliance with GxP requirements consistently.

•     Identify validation requirements for proposed changes and corrective actions.

•     Present validation status of systems and processes to Regulatory Agencies and at customer quality audits.

•     Comply with corporate and site safety procedures.

 

Who you are:

Education and Qualification Required

Education:

•     BS in automation, IT, Pharmaceutical or equivalent.

•     More than 5 years’ CSV experience in pharmaceutical plant.

•     Familiar with GAMP5 and GxP requirements.

•     Experience and knowledge in CSV, qualification and validation.

Job specific Competencies & Skills:

•     Fluent in English

•     Result orientation, accuracy and reliability as a must

•     Excellent communication, problem-solving, planning and organization skills

 

Functional area: Quality


What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com

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