CSV Lead

Job Roles & Responsibilities:

• Develop validation strategies, protocols, and documentation plans for systems, processes, and equipment used in GxP-regulated environments (Validation Plan).

• Execute validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), in accordance with established procedures and regulatory requirements.

• Perform risk assessments (IRA/HLRA) to identify critical processes and parameters, and ensure appropriate controls are implemented to mitigate risks.

• Collaborate with internal stakeholders to coordinate validation activities, including scheduling, resource allocation, and communication of validation status.

• Review and approve validation documentation, including protocols, reports, and deviations, ensuring compliance with regulatory requirements and internal quality standards.

• Provide technical expertise and guidance on validation activities, including troubleshooting issues and resolving deviations or discrepancies.

• Conduct periodic reviews and revalidation of systems, processes, and equipment to ensure continued compliance with GxP regulations.

• Participate in cross-functional teams to support the implementation of new systems or process changes, providing input on validation requirements and ensuring compliance with regulatory standards.

• Stay current with changes in GxP regulations, guidelines, and industry best practices related to validation, and incorporate updates into validation processes and procedures.

• Support regulatory inspections and audits (internal and external) by providing documentation and evidence of validation activities as required, assisting in addressing any findings or observations.

• Strong understanding of GxP regulations, including GDP, GLP, GMP, and GCP requirements, as well as validation principles and methodologies.

• Strong understanding of regulatory requirements and guidelines including FDA regulations (21 CFR Part 11, 210, 211), EU GMP Annex 11, cGAMP and relevant international standards (e.g., ISO 13485, ICH).

• Familiarity with risk assessment techniques (e.g., FMEA) and their application to validation activities.

• Excellent analytical and problem-solving skills, with the ability to identify and address complex validation issues effectively.

• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate technical information clearly and concisely.

• Provide training and support to Jr members on GxP compliance and CSV-related topics.

• Certification in GxP-related disciplines (e.g., Certified GxP Professional or CSV) is a plus

Other Essential Skills:

• Good project management and hands on experience on end-to-end Validation of Computerized Systems (CSV)

• Experience in SAP QM module, any other QMS systems

• Strong functional knowledge of Pharmaceutical Manufacturing and Quality Process.

• Ability to work in a geographically separated team in different time zones.

• Contribute to innovation and process improvement efforts.

• 5+ years of experience in an FDA-regulated environment.

• 5+ years of pharmaceutical Quality Assurance or Validation experience is preferred.

• Knowledge and experience of IT-OT Integration.

Educational Qualification: B. Pharm/B. E or above from a Reputable Institute.

Experience: 8 to 10 years of Relevant Experience