Validation Specialist

Perform QA oversight for validation of equipment and packaging qualificationPerform review and approval of equipment validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.Provide quality support for testing strategies and quality investigations.Perform review and approval of master data in the electronic batch record platform (PASX).ResponsibilitiesProcess, equipment and IS validationAgrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.Reviews and approves validation documentation.Maintenance & Engineering supportReviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …)Device and combination productManages device responsibilities and ensures alignment with GMP regulations.PASX master dataReview and approved master data in PASX system as QA.Change controlPerforms final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.Deviation managementFunctions as QA contact for deviation records.QualificationsMUST RequirementsMBO or Bachelor’s degree in Life Sciences or process technology related field or the equivalent combination of education and/or experience.Typically 3+ years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.Manufacturing and/or Quality analytical processes and operations.Fluent in English language.Preferred RequirementsExperience with pharmaceutical industryExperience with Deviations and Change ControlInterested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info.