takeda

Validation specialist (BB-DA834)

Gefunden in: Talent CH

Beschreibung:
Job Description:As Validation Specialist you will be responsible for validation strategy definition, planning, execution and reporting of validation tasks within the Manufacturing Sciences department. The role responsibility covers developing strategy, writing both protocols and final reports, as well as ensuring execution of Process Validation for the site.As Validation Specialist you will have an active involvement in continues improvement, development and implementation of new initiatives. You will assure issue resolution arising from validation activities in cooperation with Quality, Technical Operations and Manufacturing deviation handling, CAPA and change requests).The role is expected to have a solid understanding of industry standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards.Your mission: The Validation Specialist performs, troubleshoots and supports the manufacturing validation activities. He/she represents the validation on project teams and interfaces with peers in various other departments such as engineering and manufacturing to ensure Validation strategy and execution are conducted according to established quality standards as well as Regulatory requirements.Essential Duties & Responsibilities :Maintain and develop expertise Process Validation according to Takeda and Regulatory standardsElaborate validation strategy and write validation plan according to Takeda standards procedures.Write, review and approve Validation documents (validation protocols/reports, SOPs, RIAS, according to Takeda and Regulatory standardsParticipate in validation activities from planning, execution to validation reportsCoordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.Provide Validation support related to strategy definition, problems solving, root cause analysis, CAPAs investigation and implementation stepsParticipate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on timeParticipate in the “community of practices” within validation Takeda network.Required Skills:We are looking for a strong energetic team player with good communication skills,Ability to lead effectively and efficiently validation engineering topicsAbility to manage multiple priorities in a manufacturing plant settingAbility to analyze, review and interpret validation dataMust have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelinesInterpersonal skills that enables you to work with people at all levelsAbility to plan, multitask, and manage time effectivelyMust display eagerness to learn, to innovate, drive for solutions and continuously improvementRequirements:Engineering degree or equivalent, preferably with biochemical or chemical backgroundAt least 5 years’ experience in validation in a pharmaceutical/biotechnology industry.Experience in Validation Strategy elaboration for complex and multiproduct manufacturing linescGMP skillsBroad validation knowledge, industrial trends and validation related literatureSolid computer skills including Word, Excel, PowerPoint.Very good French level (oral and written)Good English level (oral and written)

calendar_todayvor 4 Tagen

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location_on Neuchatel, Schweiz

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