Csv Consultant ( Barcelona, Spain) (Madrid)

Csv Consultant ( Barcelona, Spain) (Madrid)

12 oct
|
Pharmax Solutions
|
Madrid

12 oct

Pharmax Solutions

Madrid

We’re Hiring: CSV Consultant | PharmaX Solutions|Location: Barcelona, SpainAre you passionate about Computerized System Validation (CSV), GxP compliance and data integrity ? Do you enjoy working directly with clients and solving complex challenges in the life sciences industry?PharmaX Solutions is looking for a CSV Consultantto join our growing team and work on exciting projects across the pharmaceutical and life sciences sector.What you’ll doAs aCSV Consultant, you will work closely with clients and cross-functional teams to ensure that computerized systems and processes meet applicableGxP and regulatory requirements .Your responsibilities will include:PerformingComputerized System Validation (CSV)activitiesEnsuring compliance withGxP regulations and industry standardsSupporting data integrityandALCOA+principlesPreparing for and supportingregulatory audits and inspectionsIdentifying and managing compliance and validation risksSupporting and improving Quality Management Systems (QMS)Working with clients to understand their needs and develop practical compliance solutionsCollaborating with technical, quality and business teamsPreparing and reviewing validation and compliance documentationWhat we’re looking forYou bring1–5 years of experiencein one or more of the following areas:Computerized System implementation, Validation and change controlValidation of complex systems such as MES, SAP,



LIMs.GxP-regulated environmentsYou should also have:Good knowledge ofGxP regulations and guidelines, including FDA 21 CFR Parts 11, 210 & 211, EU GMP, ICH, GAMP 5 and ISPEUnderstanding ofGood Documentation Practices (GDP)andALCOA+principlesExperience or familiarity with GxP systems such asTrackWise, Veeva Vault or similar platformsFamiliarity with validation tools such as HP ALM, KNEAT or ValGenesisGood working knowledge of Microsoft Office, particularly Excel, Word and PowerPointStrong analytical and problem-solving skillsExcellent communication and interpersonal skillsAbility to manage multiple projects and prioritiesA collaborative, proactive and client-focused mindsetEducationBachelor’s degree inLife Sciences, Chemistry, Pharmacy, Biotechnology, IT, Engineeringor a related fieldLanguagesEnglish:Strong working/technical proficiency (minimum B2 level)Why PharmaX?At PharmaX, you’ll have the opportunity to:Work on real-world projects within thepharmaceutical and life sciences industryCollaborate with international clients and cross-functional teamsDevelop your expertise in GxP, CSV, validation and digital complianceWork in a growing and collaborative environmentMake a direct impact on quality, compliance and patient safetyIf you're ready to take the next step in yourCSV/GxP career, we’d love to hear from you.#J-18808-Ljbffr

📌 Csv Consultant ( Barcelona, Spain) (Madrid)
🏢 Pharmax Solutions
📍 Madrid

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