Executive, CSV - Quality

Job Responsibilities

JOB DESCRIPTION

• 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

Qualifications

B-Pharmacy, M-Pharmacy

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role : Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role : Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role : Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role : Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.

Service Role : Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Skills Required

Proficiency in writing validation documents URS FS RA IQ OQ PQ VSR, SDLC System Development Life Cycle and risk-based validation, 21 CFR Part 11 and Annex 11 compliance, CSV lifecycle and GAMP 5 guidelines, Exposure to Computer Software Assurance CSA approach