Validation Engineer (For Well known MNC)

Role & responsibilities

• Maintains equipment validation master plans (VMP), traceability matrices, test case protocols, test cases, validation reports and summary reports for companies operating equipment.
• Determine validation approach for projects, write project validation plan (PVP) .
• Ensure and maintains validation status of cleanroom, water system, cleaning validation, washing validation.
• Reviews completed validation documentations (URS, QCDS, FAT, SAT, PQ etc.) to ensure actual results meet expected results.
• Ensures that all validation deviations are resolved, documented and reviewed for regression testing
• Oversees the review of operating equipment changes including impact assessment and presents to relevant management.
• Defines and develops validation schedules to ensure that all companies production equipment are periodically reviewed and assessed for revalidation
• Develops reviews and revises standard operating procedures (SOPs) consistent with ISO, ASTM-2500E and European Union (EU) regulations and customer requirements.
• Develops processes to maintain validated equipment status per the approved VMP.
• Provides technical support during internal/external audits and regulatory inspections.
• To work closely with all department and the Quality Department to ensure the operation of a validated environment according to GMP and regulatory requirement.
• Manage database for SOPs and validation documents (Pilgrim and Lotus Note) with proper tracking for timely closure of documents
• Develops reviews and revises standard operating procedures (SOPs) consistent with ISO, ASTM-2500E and European Union (EU) regulations and customer requirements.
• To continue to develop and implement an efficient complaint and cost effective calibration and maintenance program for GMP critical manufacturing equipments
• Coordinate calibration activities among the cross function team including external parties Review calibration records and maintained as per ISO/IEC 17025 guideline.
• Participate in different (Global/Local projects).
• Continuous improvement project (CIP), 5s, companiesProduction System (DPS)

Preferred candidate profile

• Qualification : B. Pharma / M. Pharma / M.Sc
• Candidate should have 2 to 7 years of experience.