takeda T

Quality Compliance Self-Inspection Sr Specialist (BB-757E5)

Trouvé dans: Xpatjobs BE

Job DescriptionSummary of Primary Duties:The Quality Compliance Self-Inspection Sr Specialist is responsible for the development and execution of self-inspection program, and oversight of related corrective action plans and internal education as necessary.In conjunction with Compliance leadership, he/she will develop an annual auditing and monitoring plan.He/she will conduct auditing (locally and across the Manufacturing sites of the company) and monitoring activities and review necessary documents to determine compliance with regulations and/or policies and procedures. He/she will prepare written reports of audit results including recommendations for improvement and investigations as necessary.He/she will oversee the Self-Inspection CAPA program. Track the CAPA investigations and ensure they are being completed on time with appropriately documented investigations, corrective action plans, effectiveness checks, etc.He/she will evaluate the adequacy of the provided evidence against the approved Audit Action Plan. The Quality Compliance Self-Inspection Sr Specialist will participate actively to the site compliance program including inspection readiness program, GMP/Compliance walkthroughs, external and internal audits, gap assessments, and delivery of continued education on GMP and Compliance; the preparation and maintenance of key quality indicators and site metrics for the appropriate communication to Site Leadership and Global teams.Responsibilities:Schedule, prepare, conduct, document, and follow-up of assigned GxP walkthroughs, self-inspections in accordance with Takeda corporate standardsProvide guidance on mitigation/resolutionMaintain inspection readiness plan, conduct inspection readiness training, and coordinate support staffMaintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements and by delivering continued education on GMP and ComplianceDrive Inspection readiness projects and assist other areas within the facility in understanding FDA, EU, and other quality requirementsHave a key role during inspections preparation room coordinator, inspection liaison, and/or inspection host during inspections)Compile and/or review various key quality indicator trends/metric data at defined frequencies.Prepare and report trend and metric data via management review operating mechanismsEducation and Experience Requirements:High school / university degree in biology, biochemistry, industrial or chemical engineeringMinimum 5 years of experience required as a Quality Auditor in a regulated pharmaceuticalPrefer experience with supporting HA inspections, FDA, MoHsKey Skills, Abilities, and Competencies:Strong knowledge of regulatory regulations, cGMP, and Quality Systems is requiredBe a self-driven individual who requires minimal supervisionAbility to handle audit situations and interaction in a tactful, professional and effective mannerMust have excellent time management, organizational skills, verbal and written communication skills; able to efficiently communicate with cross- functional teams (locally and globally) and managementProject management capabilitiesDemonstrate ability to lead / facilitate group discussions in a constructive and positive direction.Demonstrate effectiveness in ability to train othersPossess proficient computer skills and be experienced using MS Office Tools and Microsoft Teams.Must be able to enter laboratory and manufacturing environmentMust be able to travel approximately 50% - internationalFluent in written and spoken EnglishFluent in written and spoken French

calendar_todayil y a 4 jours


location_on Lessines , Walloon Region, Belgique

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