Validation Manager - Pune, India - Scitara Corporation

Description

Job Title : Manager CSV

Role Description

• Manager 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 activities
• Good knowledge of IT and application development
• Direct Customer interaction and participation in customer facing meetings and demonstrations is a part of this function.
• Should be self-motivated and individual contributor.

Key Responsibilities

• To 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 Reports
• To 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 Management
• Internal and External Audits
• Conducts 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 Candidate

Educational Qualifications

Engineering OR Bachelors/Master's Degree in Chemistry/Biochemistry or related Science Streams. Alternatively, an advanced degree in Computer Engineering with related laboratory experience

Experience

Total 15+ years of experience in life science or related market industry with extensive experience in CSV

Should have worked in CSV and Quality Assurance for at least 7+ years

Desired Skills

• Exposure and understanding of Good automated manufacturing practice (GAMP) is a must.
• Detailed knowledge of Good Manufacturing Practices, Computer System Validation requirements
• Should 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 Management
• Should 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 11
• SDLC/Waterfall and STLC and Testing Methodologies
• Quality Management Systems (Experience in Quality Function)
• Excellent written and verbal communication skills
• Excellent teamwork skills