ERP Validation Consultant

The position is charged with supporting the implementation of an Enterprise Resource Planning (ERP) System, including support for system implementation activities, system validation activities, system hypercare activities, and ensuring compliance with our client's policies and procedures.

• Support ERP system validation activities including validation planning, requirements gathering, design review, test planning and execution, and validation reporting. Includes authoring responsibility for validation lifecycle documentation and discrepancy management.
• Apply risk-based methodology, including concepts of Computer Software Assurance (CSA) and critical thinking, to interpret and apply the strategy provided by validation leadership to the needs of the ERP system implementation.
• Support the development of operational phase needs for the ERP system, including change management, user access review, audit trail review, business continuity, and disaster recovery.
• Support risk assessment and data integrity assessment initiatives as a validation/compliance SME to ensure the ERP system meets current industry expectations and company requirements.
• Follow-up on requests, issues, and projects, and report status to management / department leadership / working teams.
• Lead Data Integrity assessment for the ERP system.

Requirements

ACADEMIC/TECHNICAL QUALIFICATIONS:

• Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background.
• Minimum of 4-6 years of experience supporting computer systems compliance activities in a high volume commercial / clinical pharma / healthcare facility.
• Experience supporting the implementation of ERP Systems in the biopharmaceutical industry.
• Understanding of industry standards and best practices for computer system compliance such as GAMP 5 and Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
• Knowledge of Regulatory Compliance and ICH Guidelines.
• Practical experience with quality risk management and execution of risk-based approaches in support of computer system compliance activities.
• Practical experience with use of concepts of Computer Software Assurance (CSA) and critical thinking.
• Experience with automated testing tools preferred.

REQUIRED COMPETENCIES:

·         Excellent written and verbal communications, including technical writing.

·         Self-motivated, able to produce high volume of work with limited supervision.

·         Organized, able to manage multiple assignments and work effectively under pressure.

Benefits

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.