AddressGXP Validation Engineer
Exp:5-7 Yrs.
Job Description:
- Develop validation strategies, protocols, and documentation plans for systems, processes, and equipment used in GxP-regulated environments.
- 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 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, assist in addressing any findings or observations.
- Strong understanding of GxP regulations, including 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, and relevant international standards (e.g., ISO 13485, ICH).
- Familiarity with risk assessment techniques (e.g., FMEA, HACCP) 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.,
