Executive, CSV
1 day ago
Job Responsibilities
- Review CSV deliverables: Validation Plan, User Requirements (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports.
- Perform system risk assessments to identify GxP impact and required validation.
- Review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, MHRA, ICH Q7/Q9 guidelines.
- Support audits and inspections (internal, regulatory, client).
- Collaborate with IT, QA, Manufacturing, and Business to ensure validation of ERP, LIMS, MES, CDS, QMS, and other GxP systems.
- Maintain validation documentation as per SOPs.
- Participate in Change Control, CAPA, and Deviation management related to computerized systems.
- Provide training and guidance on CSV processes and best practices.
- Contribute to transitioning from CSV to CSA (Computer Software Assurance) approach where applicable.
Technical Skills Required
CSV lifecycle and GAMP 5 guidelines : Advanced
21 CFR Part 11 and Annex 11 compliance : Advanced
Proficiency in writing validation documents (URS, FS, RA, IQ/OQ/PQ, VSR) : Advanced
SDLC (System Development Life Cycle) and risk-based validation: Advanced
Exposure to Computer Software Assurance (CSA) approach : Advanced
QualificationsB-Pharmacy, M-Pharmacy
-
CSV Specialist
3 weeks ago
Ahmedabad, Gujarat, India, Gujarat Adrta Technologies Private Limited Full timeJob Summary:We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
CSV Specialist
2 weeks ago
Ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary:We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
CSV Specialist
5 days ago
ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary:We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
CSV Specialist
2 weeks ago
Ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary:We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
Csv specialist
2 weeks ago
Ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary: We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
Csv specialist
2 weeks ago
Ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary: We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
CSV Specialist
2 weeks ago
Ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary: We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
CSV Specialist
3 days ago
ahmedabad, India Adrta Technologies Private Limited Full timeJob Summary: We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
-
CSV - IT Specialist
8 hours ago
Ahmedabad, India Zydus Group Full timeYour Next Big Career Move Starts Here! Join Zydus Today! Dear Change-Makers , Let’s Build Healthier Communities Together at Zydus!! About Zydus We are an innovation-driven global healthcare leader, committed to discovering, manufacturing, and marketing therapies that make a difference. With 27,000+ employees worldwide and 1,400+ scientists driving...
-
CSV - IT Specialist
2 days ago
Ahmedabad, Gujarat, India Zydus Group Full time ₹ 5,00,000 - ₹ 15,00,000 per yearYour Next Big Career Move Starts Here Join Zydus TodayDearChange-Makers,Let's Build Healthier Communities Together at ZydusAbout ZydusWe are an innovation-driven global healthcare leader, committed to discovering, manufacturing, and marketing therapies that make a difference. With 27,000+ employees worldwide and 1,400+ scientists driving research, we are...
