Junior It & Compliance Consultant (Life Sciences)

Qualitice
Álava, Spain
12 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English, German

Tech stack

Data Integrity Laboratory Information Management Systems SAP (Applications) Verification and Validation (Software) System Testing Veeva GXP

Job description

Join Qualitice - Junior IT & Compliance Consultant (Life Sciences)¿Quiere presentar una candidatura?Asegúrese de que su CV está actualizado y luego lea atentamente las siguientes especificaciones del puesto antes de solicitar.Launch your consulting career in Digital Quality & Compliance.Are you passionate about technology, digital transformation and the pharmaceutical industry?Do you want to work on international projects while learning from experienced consultants?At Qualitice, we help leading pharmaceutical, biotechnology and medical device companies deliver compliant digital transformation programmes.Our projects combine IT, Quality, Compliance and Project Management in highly regulated environments.We’re looking for a motivated Junior IT & Compliance Consultant (m/f/d) to join our growing team and develop into a future Computer System Validation (CSV), Computer System Assurance (CSA) or Digital Quality Consultant.No prior CSV experience is required-we’ll provide comprehensive training and mentoring.What You’ll Be DoingSupporting Computer System Validation (CSV) and Computer System Assurance (CSA) projectsAssisting with validation documentation, testing and quality reviewsSupporting implementation projects for systems such as ERP, Veeva, LIMS, MES and eQMSParticipating in GxP risk assessments, supplier assessments and Data Integrity activitiesCoordinating project tasks and collaborating with international client teamsResearching and applying regulatory requirements such as GxP, GAMP 5, Annex 11 and 21 CFR Part 11Supporting audit and inspection readiness activitiesLearning from experienced consultants while taking on increasing responsibilityWhat We’re Looking ForBachelor’s or Master’s degree in one of the following:Computer ScienceInformation TechnologyEngineeringLife SciencesPharmacyBiotechnologyBiomedical EngineeringBusiness Informaticsor a related disciplineStrong interest in digital transformation, IT and regulated industriesExcellent analytical and problem?solving skillsProactive, structured and eager to learnComfortable working in an international environmentFluent English (required)German is desirable and a significant advantageKnowledge of pharmaceutical processes, quality management or software validation is a plus, but not required.What You’ll LearnComputer System Validation (CSV) and Computer System Assurance (CSA)GAMP 5 (Second Edition)GxP ComplianceData IntegrityRisk ManagementProject ManagementLeading enterprise platforms such as SAP, Veeva, LIMS and MESWhy Join Qualitice?Work with leading international pharmaceutical, biotechnology and medical device companiesFlexible remote?first working modelOpportunities to travel across Germany, Switzerland and EuropeStructured mentoring by experienced senior consultantsFast professional development with increasing responsibilityJoin a growing specialist consultancy focused on Digital Quality & ComplianceFriendly, international and entrepreneurial team cultureLocationRemote (Europe) with occasional travel to client sites.Candidates must be legally authorised to work within the European Union.xqbhyrx CompensationCompetitive salary based on experience, plus excellent opportunities for professional development.#J-*****-Ljbffr

Requirements

Our projects combine IT, Quality, Compliance and Project Management in highly regulated environments.We’re looking for a motivated Junior IT & Compliance Consultant (m/f/d) to join our growing team and develop into a future Computer System Validation (CSV), Computer System Assurance (CSA) or Digital Quality Consultant.No prior CSV experience is required-we’ll provide comprehensive training and mentoring.What You’ll Be DoingSupporting Computer System Validation (CSV) and Computer System Assurance (CSA) projectsAssisting with validation documentation, testing and quality reviewsSupporting implementation projects for systems such as ERP, Veeva, LIMS, MES and eQMSParticipating in GxP risk assessments, supplier assessments and Data Integrity activitiesCoordinating project tasks and collaborating with international client teamsResearching and applying regulatory requirements such as GxP, GAMP 5, Annex 11 and 21 CFR Part 11Supporting audit and inspection readiness activitiesLearning from experienced consultants while taking on increasing responsibilityWhat We’re Looking ForBachelor’s or Master’s degree in one of the following:Computer ScienceInformation TechnologyEngineeringLife SciencesPharmacyBiotechnologyBiomedical EngineeringBusiness Informaticsor a related disciplineStrong interest in digital transformation, IT and regulated industriesExcellent analytical and problem?solving skillsProactive, structured and eager to learnComfortable working in an international environmentFluent English (required)German is desirable and a significant advantageKnowledge of pharmaceutical processes, quality management or software validation is a plus, but not required.What You’ll LearnComputer System Validation (CSV) and Computer System Assurance (CSA)GAMP 5 (Second Edition)GxP ComplianceData IntegrityRisk ManagementProject ManagementLeading enterprise platforms such as SAP, Veeva, LIMS and MESWhy Join Qualitice? Work with leading international pharmaceutical, biotechnology and medical device companiesFlexible remote?first working modelOpportunities to travel across Germany, Switzerland and EuropeStructured mentoring by experienced senior consultantsFast professional development with increasing responsibilityJoin a growing specialist consultancy focused on Digital Quality & ComplianceFriendly, international and entrepreneurial team cultureLocationRemote (Europe) with occasional travel to client sites.Candidates must be legally authorised to work within the European Union.

Benefits & conditions

xqbhyrx CompensationCompetitive salary based on experience, plus excellent opportunities for professional development. #J-*****-Ljbffr

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