Validation Engineer
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Ensure manufacturing process (including equipment, methods) are appropriately qualified and validated while conducting review of related documentation and leading quality risk assessment and change management activities.
VALIDATION ACTIVITIES
Lead and execute validation activities that are identified and required. Prepare all the documentation associated by ensuring the execution following the plan. Ensure that all validation activities are carried out and reported in a timely manner. Ensure that all deviations during validation activities are investigated and escalated when required. Propose action plans and ensure that correctives/preventives actions are followed and closed on time.
VALIDATION SUSTAINABILITY
Organize and lead the Continued Verification Assessment and the 1 /4 JOB DESCRIPTION re-execution of validation protocols according to the plan and procedures. Provide reports and other documentation associated with validations, as appropriate for each validation exercise.
CHANGE MANAGEMENT
Lead and coordinate change management process in the factory and ensure validated state of the manufacturing processes, methods and systems is maintained. Ensure the reporting and the update of key metrics.
RISK-ASSESSMENT
Provide support and act as SME / Facilitator for the Quality Risk Assessment. Ensure the appropriate methodologies are implemented and mitigation plans defined and followed up by the relevant responsible persons as per established quality requirements.
COMMUNICATION & PROJECT
Provide full support by sharing expertise and knowledge to business owners and relevant stakeholders. Through effective communication and training initiatives, develop cross-functional and cross-departmental staff (in projects and validation teams) to ensure that validation projects are carried out in accordance with internal Policies and Procedures. Ensure compliance through assisting in audits.
QMS SUPPORT
Participate to the creation/update of procedures, work instructions and others Quality Documents that are required. Provide support and training by ensuring a transfer of knowledge according to the training management system.
HEALTH, SAFETY AND ENVIRONMENT
Promote and apply all rules concerning PMI Quality, environment, health and safety. Report all situations requiring actions in order to minimize or eliminate risks exposure to personnel, company assets and societal impacts and be in line with or ahead of any applicable Law requirements and Company standards.
College/University Honors / Masters degree in Biological sciences, Physical sciences, Chemistry, Engineering or equivalent education
Work experience: 3-5 years experience in quality assurance in tobacco, food, pharmaceutical or similar industry and/or 3-5 years experience as a specialist in a relevant area of activity.
Approachability Action Oriented Interpersonal Savvy Customer Focus Learning on the fly Listening Organizing Integrity & Trust Peer Relationships Composure Problem Solving Priority Setting Organizational Agility Language Skills
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