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quality specialist in Lessines

Lessines, Hainaut
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job description

-Responsible for managing multiple labeling change control projects encompassing a varying degree of scope and complexity. -Support labeling team project initiatives. -Support relabeling change controls -Provide with change control guidance and oversight to the Baxter EMEA MP plants not part of the change control centralization -Responsible to understand and comply with change control and labeling design and development procedures -Collect and consolidate information required to initiate change controls related to label changes -Liaise with the Subject Matter Experts from the different functions (Regulatory, Labeling Center, Manufacturing, R&D, Quality) and coordinate the assessments supporting label change controls -Organize the change control activities in a compliant change plan -Lead and closely track the change control execution and implementation activities related to Labeling Change Requests -Collect, analyze, evaluate data to identify trends or anomalies and escalate as appropriate -Support the implementation of the QMS in labeling change control team to ensure that all relevant SOP's are in place and comply with Baxter policies, EMEA, Local and Corporate requirements, -Support audit and inspection program as well as Baxter MP manufacturing plants in case of internal and external inspections (for labeling process) -When required, provide support and expertise for CAPA related to labeling. Act as CAPA owner, CAPA investigator or QA Approver -Support training program of EMEA labeling team, ensure training records are maintained. Deliver training upon request or when required to other personnel (e.g.: RA, Supply Chain, Quality Mfg)


-Master degree in life-science or engineering -1 to 3 years industry experience in Pharmaceutical or Medical device related industry. -Excellent level of English (Spoken, Read, Written) -Critical thinking and the ability to challenge the status quo -Have a pragmatic approach, hands-on attitude -Strong analytical/problem solving skills -Customer focus -Results oriented with a process and quality driven approach -Self-driven with the ability to work independently as needed -Excellent team-work and collaboration skills -Strong communication skills: needs to cascade information both ways and ensure consistent, concise, clear messages to all, influence others skills -Eagerness to learn, strong motivation -Positive approach, optimism Intérim de 6 mois minimum (prolongeable) Lieu de travail : Lessines Horaire: Jour Salaire: 3115 euros brut
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