Validation Analyst

Location: Delhi, Delhi, India | Experience: Mid Level (3-5 years)

About the Company

Our client is a pharmaceutical organization operating in a highly regulated environment where product quality, patient safety, data integrity, and reliable processes are business-critical. The organization works across cross-functional teams including Quality Assurance, Manufacturing, Engineering, Information Technology, Research and Development, and regulatory stakeholders. Its operating model depends on controlled systems, documented procedures, risk-based decision-making, and consistent adherence to applicable Good Manufacturing Practice requirements. The company expects employees to take ownership of accurate records, timely issue resolution, and inspection-ready documentation. Collaboration is central to the way teams deliver results, particularly when validating facilities, equipment, utilities, processes, analytical methods, or computerized systems. This role will contribute to strengthening compliant operations by ensuring that validation activities are planned, executed, reviewed, and maintained according to approved standards. The successful candidate will join a quality-focused environment where disciplined execution, clear communication, and continuous improvement support dependable pharmaceutical operations and sustained business performance.

About the Role

The Validation Analyst owns the planning, execution, review, and maintenance of validation activities supporting pharmaceutical operations. Through approved protocols, risk assessments, change controls, deviations, and controlled reports, the role ensures that equipment, utilities, processes, facilities, analytical methods, or computerized systems remain fit for intended use and compliant with GMP expectations. The analyst translates requirements into practical validation deliverables, coordinates evidence collection across functions, and escalates gaps before they affect quality, timelines, or inspection readiness. Success is measured by complete and accurate documentation, timely closure of discrepancies, strong traceability, and sustained validated-state performance.

Key Responsibilities

• Prepare and execute validation protocols, including IQ, OQ, PQ, process validation, cleaning validation, method validation, and computerized system validation activities as applicable.
• Review requirements, specifications, risk assessments, test scripts, raw data, and completed records to confirm traceability, accuracy, and compliance with approved procedures.
• Coordinate with Quality Assurance, Manufacturing, Engineering, IT, laboratories, and vendors to schedule activities, resolve findings, and maintain project milestones.
• Investigate deviations, discrepancies, and out-of-specification validation results using documented root-cause methods and support effective corrective and preventive actions.
• Maintain validation plans, master plans, periodic reviews, change controls, validation reports, and lifecycle records in controlled document or quality systems.
• Support audit and regulatory inspection readiness by retrieving objective evidence, explaining validation rationale, and ensuring commitments are closed within agreed timelines.
• Monitor validated-state performance and identify recurring issues, documentation weaknesses, or process risks requiring improvement or requalification.

Essential Skills & Technologies

• Strong understanding of GMP, GxP, data integrity, validation lifecycle principles, risk management, deviation management, CAPA, and change control in pharmaceutical operations.
• Hands-on experience preparing protocols, executing testing, analyzing results, and writing validation reports with clear evidence, traceability, and defensible conclusions.
• Working knowledge of quality management systems, electronic document systems, Microsoft Office, and relevant tools used to manage validation records and compliance workflows.

Additional Plus

• Experience with computerized system validation, 21 CFR Part 11, EU Annex 11, audit trails, and electronic records in regulated pharmaceutical environments.
• Exposure to facility, utility, equipment, cleaning, process, analytical method, or packaging validation projects across manufacturing or laboratory operations.
• Familiarity with statistical analysis, sampling plans, technical writing, and vendor qualification activities would strengthen performance in the role.

What You'll Bring

• A bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, Engineering, or a closely related discipline, supported by 3–5 years of pharmaceutical validation or quality experience.
• Practical experience working in GMP-regulated environments and applying validation procedures to equipment, utilities, processes, analytical methods, facilities, or computerized systems.
• The ability to interpret technical requirements, build logical test evidence, identify compliance gaps, and communicate clear conclusions to both technical and non-technical stakeholders.
• Strong documentation discipline, including accurate review of raw data, protocol deviations, validation reports, change controls, CAPAs, and controlled records.
• A proactive approach to issue ownership, with the judgment to escalate risks early and coordinate effective resolution without compromising data integrity or quality standards.
• Comfort working across functions, managing multiple priorities, meeting validation timelines, and maintaining inspection readiness in a collaborative hybrid environment.

Why Join Us

• Own validation outcomes that directly support product quality, patient safety, compliance confidence, and dependable pharmaceutical operations.
• Work with cross-functional specialists on meaningful GMP projects, gaining broad exposure to quality systems, manufacturing, engineering, laboratories, and regulated technology.
• Build a visible career foundation in validation through structured documentation, problem-solving, audit readiness, and continuous improvement across the validation lifecycle.

What We Offer

• A hybrid working environment with opportunities to collaborate closely with Quality Assurance, Manufacturing, Engineering, IT, laboratory, and project stakeholders.
• Exposure to diverse pharmaceutical validation initiatives and regulated processes that strengthen technical capability and quality-system expertise.
• An ownership-oriented culture where accurate work, proactive communication, and timely issue resolution are recognized as contributors to compliance and business performance.