ERP/SAP. CSV Consultant

We are seeking a highly skilled and experienced TQ CSV (Computer System Validation) Specialist to perform pre- and post-review activities for critical projects. The successful candidate will bring a deep understanding of CSV processes, expertise in SAP/ERP systems, and a strong ability to lead and mentor junior and senior team members. Certifications in premier/recognized areas of expertise are required.

Key Responsibilities:

Validation Oversight:

Conduct pre- and post-validation reviews of computer systems to ensure compliance with industry standards and regulatory requirements.

Prepare and review validation plans, test scripts, risk assessments, and summary reports.

Leadership and Mentorship:

Provide guidance and direction to junior and senior team members, fostering a collaborative and high-performing environment.

Advise on best practices and emerging trends in computer system validation.

SAP/ERP Expertise:

Leverage in-depth knowledge of SAP/ERP systems to validate and optimize system functionality.

Collaborate with cross-functional teams to ensure integration and compliance of SAP/ERP systems with validation protocols.

Compliance and Documentation:

Ensure all validation activities adhere to applicable regulatory standards (e.g., FDA, EMA, ISO).

Maintain accurate and comprehensive documentation throughout the validation lifecycle.

Continuous Improvement:

Identify opportunities for improving validation processes and implementing innovative solutions.

Stay current with advancements in technology, tools, and regulations. Qualifications:

Experience: 7-10 years of relevant experience in computer system validation, including pre- and post-review activities.

Leadership Skills: Proven ability to lead and mentor diverse teams, including junior and senior professionals.

Technical Expertise: Strong background in SAP/ERP systems and related validation processes.

Certifications: Possess premier/recognized certifications in areas such as:

Certified Computer System Validation Professional (CCSVP)

SAP Certification in relevant modules

PMP (Project Management Professional) or equivalent

Other recognized validation or regulatory certifications

Regulatory Knowledge: Familiarity with industry regulations and standards, including GxP, FDA CFR Part 11, and ISO 9001.

Soft Skills: Excellent communication, analytical, and problem-solving skills.