QA Specialist (equipment & system validation) - Undutchables

pbPlease note before applying: Only candidates with a valid work permit for the Netherlands will be considered for this role. This role does NOT offer sponsorships options. /b /ppAs QA Specialist, you will provide quality oversight for the validation and lifecycle management of equipment, automation and information systems. You will review technical documentation, advise different departments on GMP requirements and ensure that quality and compliance considerations are incorporated into technical decisions. /ph3Responsibilities /h3ulliReviewing and approving equipment, automation and information system validation documentation. /liliProviding QA guidance regarding the design, characterization and validation of equipment and systems. /liliEnsuring validation activities comply with GMP, internal quality standards and regulatory requirements. /liliReviewing and approving technical changes to equipment, including parameter changes and like-for-like assessments. /liliReviewing changes to Maintenance Engineering procedures, including preventive and corrective maintenance and changeover processes. /liliProviding quality engineering support for testing strategies, investigations and technical quality issues. /liliSupporting quality activities related to devices and combination products and ensuring alignment with applicable GMP requirements. /liliRepresenting QA in Quality Risk Management (QRM) activities, including FMEA and other quality risk assessments. /liliReviewing Quality Risk Assessment reports and ensuring site activities remain aligned with corporate quality policies and strategies. /liliPerforming the final QA review of technical change controls, ensuring assessments and required actions are complete. /liliActing as a QA subject-matter expert for technical changes and coordinating input from different Quality areas. /li /ulpThis is a position with a high level of independence and responsibility. You will work with minimal supervision and manage several assignments and processes simultaneously. You will independently determine the appropriate approach for your projects while working toward defined operational and project objectives. Ultimately, your work contributes to delivering validated systems that meet corporate, site and regulatory requirements. /ph3Requirements /h3ulliA Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or a comparable field. /liliApproximately 5-8 years of professional experience within a GMP environment. /liliRelevant experience with equipment and automation validation. /liliStrong knowledge of GMP requirements. /liliExperience with equipment, automation and/or information system validation. /liliKnowledge of computerized system compliance requirements, including EU GMP Annex 11 and FDA 21 CFR Part 11. /liliExperience with Quality Risk Management tools such as FMEA. /liliExperience using statistical methods to support activities such as sampling plans and hypothesis testing. /li /ulh3Nice to have /h3ulliPrevious experience within the pharmaceutical industry. /liliExperience working with nonconformances, CAPAs and Change Control. /li /ulh3Benefits /h3ulliA challenging work environment with excellent career development programs. /liliFor this role, the company offers a competitive salary package. /liliReimbursement of travel expenses is dependable on travel distance. /lili30 Holidays. /lilicontract through Undutchables. /li /ul #J-18808-Ljbffr