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Requirements

QA Team Leader 

¤ýMANAGEMENT RESPONSIBILITIES
¡¡Organize and manage priority changes. Provide a full
¡¡support to her/his team, motivate and encourage
¡¡professional and career development so as to enable themto perform all their assignments.
¡¡Ensure the level of training her/his team in accordance with her/his individual development plan.
¡¡Support the organization by defining and providing
¡¡accurate KPI''s. Propose actions in order to improve our
¡¡Quality and Performance.
¡¡
¤ýPRODUCTION & LAB SUPPORT
¡¡Ensure a full QA technical support is provided to the floor during production. Ensure that quality
¡¡practices/requirements are shared and deployed on the floor by transferring the knowledge and training
¡¡stakeholders on new processes, requirements, methods or guidelines.
¡¡Ensure a robust process is in place to manage sample
¡¡testing between the Floor and Lab entities.
¡¡
¤ýDOCUMENTATION MANAGEMENT
¡¡Ensure documents are managed according to the QMS requirements. Review/approve documents raised to her/his level. Ensure that all necessary testing is carried out and the associated records evaluated and retained.
¡¡
¤ýNON-CONFORMITIES MANAGEMENT / CAPAIA
¡¡Provide a full support to the production and Lab teams in case of non-conformities and negative trends.
¡¡Support/coordinate QA team members during
¡¡investigations, risk assessment and root causes analysis.
¡¡Ensure that non-conformities are investigated in a timely manner and products/materials blocked when required.
¡¡Evaluate proposed preventives/correctives actions.
¡¡Approve/reject all non-conformities and action plan raised to her/his level.
¡¡
¤ýQMS SUPPORT
¡¡Participate to the creation/review of procedures, work
¡¡instructions and others Quality Documents that are
¡¡required. Provide the related support and training according
¡¡to the training management system.
¡¡
¤ýPROJECT / INNOVATION
¡¡Lead and/or support initiatives and cross-functional
¡¡projects related to the Quality of products and systems
¡¡(local and global projects). Provide guidance and
¡¡mentoring to other QA department team
¡¡members/Manufacturing sites.
¡¡Provide a follow up and reporting of projects and
¡¡milestones.
¡¡
¤ýPROJECT / INNOVATION
¡¡Lead and/or support initiatives and cross-functional
¡¡projects related to the Quality of products and systems
¡¡(local and global projects). Provide guidance and mentoring to other QA department team members/Manufacturing sites.
¡¡Provide a follow up and reporting of projects and
¡¡milestones.
¡¡
¤ýHEALTH, SAFETY & 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

¤ýMinimum 3 year experience in
¡¡Quality or equivalent experience is must
¤ý Minimum 2 year of people
¡¡management experience is an asset
¤ý Advanced knowledge of relevant
¡¡standards (ISO is must, GCP, ICH,
¡¡GMP, and GLP are an asset)
¤ý Advanced knowledge in Production
¡¡process / environment and statistical
¡¡tools
¤ýQualification / Validation /
¡¡Instrumentation Lab Equipment
¡¡knowledge
¤ý Project, change management skills
¤ý Good spoken and written English
¡¡and Korean communication skills are
¡¡must

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