Life Sciences Domain Consultant

Life Sciences Domain Consultant.

As a commissioning and Qualification consultant you will be the leading validation activities for clients and might also be involved handling IT Compliance audits and assurance and supporting external inspections from Regulatory bodies like FDA, MHRA, European Health Commission, Health Canada, etc.
Required Qualifications:

• Candidate must be located within commuting distance Raleigh, NC/ Bridgewater, NJ/Hartford, CT/Indian polis, IN or be willing to relocate to the area. This position may require travel in the USA.
• Bachelor’s degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
• At least 8+ years of Information Technology experience.
• Strong Quality and compliance experience.
• Performing on project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment
• Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight
• Evaluating IT and business controls, including those relevant to GxP, IT quality and 21 CFR Part 11
• Understanding of common IT risk domains, including cybersecurity, privacy, disaster recovery, change management and IT operations
• Understanding of Corrective and Preventive Action (CAPA) issues management in an FDA regulated environment
• OT System commissioning and Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
• Experience to MES, QMS (Track wise).
• PAS/DCS Qualification.
• ISA95 High level of understanding.
• OT Security will be a plus.
• PAS/DCS Integrated with Manufacturing Equipment qualification.
• Stakeholder management and good executor with required communication.
• Experience and desire to work in a management consulting environment that requires regular travel.

Preferred Qualifications:

• Knowledge of Agile/Scrum as required for Validation.
• Experience and desire to work in a management consulting environment that requires regular travel
• Planning and Co-ordination skills