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