Validation Manager

Job Title : Manager CSVRole DescriptionManager CSV is a player-coach, oversees the CSV team, leads custom validation efforts, and streamlines standard validation processes.Direct interaction with the Scitara Development, Quality and Service teams is in scope.Domain expert for validation deployment activitiesGood knowledge of IT and application developmentDirect Customer interaction and participation in customer facing meetings and demonstrations is a part of this function.Should be self-motivated and individual contributor.Key ResponsibilitiesTo ensure the project life cycle completed as per the phases and reporting the current status to the leads.Will be responsible to maintain compliance and adherence to QMS in the Services department.Will be responsible to work with customer CSV/Validation/Quality group to project Scitara's validation approach.To author the Validation deliverables like Master/Validation Plan, Validation., Test Plans and Summary ReportsTo review the User and Functional requirement documents and ensure the traceability within IQ, OQ, PQ scripts.Ensure the related testing completion.Software Quality Assurance and Risk ManagementInternal and External AuditsConducts the trainings for new resources and providing guidance for overall CSV process.Oversees the CSV team, leads custom validation efforts, and streamlines standard validation processes.Participates in customer validation projects, while also ensuring compliance is met in Services operations.Aligns validation processes with Scitara's strategic goals, ensuring continuous compliance with evolving regulatory requirements.Leads the team by example, fosters collaboration, and implements process improvements in validation activities.Participates in the selection process for the team.Effectively communicates validation strategies, progress, and challenges to customers and stakeholders, ensuring clear expectations.Ideal CandidateEducational QualificationsEngineering OR Bachelors/Master's Degree in Chemistry/Biochemistry or related Science Streams. Alternatively, an advanced degree in Computer Engineering with related laboratory experienceExperienceTotal 15+ years of experience in life science or related market industry with extensive experience in CSVShould have worked in CSV and Quality Assurance for at least 7+ yearsDesired SkillsExposure and understanding of Good automated manufacturing practice (GAMP) is a must.Detailed knowledge of Good Manufacturing Practices, Computer System Validation requirementsShould have experience in facing regulatory audits (FDA, MHRA etc.)Should have executed validation activities like executing IQ, OQ, UAT and PQ scripts for enterprise class applications.Should have resolved deviations in validation projects - Deviation ManagementShould be well versed with CAPA processes.Should have experience is facing customer audits.Domain Knowledge: Understands the Biotech or other domain related industry and how its functions demonstrate strong domain knowledge and how technology solutions can improve or enhance existing processes and overall business results; well versed in global GxP and Computer System Validation practices; solid understanding of the regulatory environment and industry standards.Regulatory experience like 21 CFR Part 11SDLC/Waterfall and STLC and Testing MethodologiesQuality Management Systems (Experience in Quality Function)Excellent written and verbal communication skillsExcellent teamwork skills PRB