Website ATS Global
Why to work for us
Join the fastest-growing system integrator in the Industrial IT Solutions space in India, offering a dynamic culture, challenging assignments with broad exposure to leading technologies, and the freedom to innovate and excel.
Role Overview
You will be responsible for driving CSV deliverables, GAMP 5 validation, URS/FRS, IQ/OQ/PQ protocols, and stakeholder-aligned solutions, while ensuring data integrity and compliance with QCMS, ISMS, and GMP/GDP/QMS practices.
Employment Type
Full-Time
Location
On-site (India)
Department
Validation
Qualification
Graduate / Master’s degree in Pharmacy, or B.E/B. Tech in technical stream.
Experience Required
2-5 Years
Travel
Yes, 100% PAN India
Job Requirements (Skill Sets)
- Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, PIC/S, WHO, MHRA, ISMS, cGMP, GDP, and Data Integrity.
- Experience in review/execution of validation documents like FS, CS, SDS, IQ, OQ and ability to draft FS/CS/DS.
- Understanding of risk, impact, criticality, and effects on patient safety, product quality, and data integrity; good knowledge of FMEA.
- Ability to read P&ID diagrams, PLC ladder logic, program configuration, and system design.
- Experience/functional expertise in at least one system: DCS, LIMS, QMS, DMS, LMS, CDAS, MES, BMS, EMS.
- Understanding of system architecture, data flow, and I/O verification.
- Good English communication and basic knowledge of IT infrastructure/network validation.
- Willing to work onsite across India.
- Preferred candidates with experience in enterprise-level software.
Key Responsibilities
- Prepare and execute CSV deliverables as per GAMP 5.
- Work with cross-functional teams to develop URS/FRS, Validation Plan, CS, IQ/OQ/PQ protocols.
- Provide timely status updates, maintain project trackers, and ensure on-time delivery.
- Execute validation activities with strict adherence to data integrity.
- Coordinate with stakeholders to ensure alignment with project objectives.
- Develop Validation Plans, Functional Specs, and Design Docs based on system architecture understanding.
- Quickly learn new technologies and prepare related configuration/design documents.
- Prepare Impact Assessments, QRM/QRA documents.
- Comply with QCMS, ISMS, and client GMP/GDP/QMS practices.
