Commissioning, Qualification & Validation Consultant

at  QA RESOURCES

EDUCATION AND EXPERIENCE:

• Requires a BS/BA in Engineering, Chemistry, or Life Sciences with 8-10+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required.
• Well versed with Microsoft tools like Word, Excel, Powerpoint etc.
  Contract: 12 Month Contract
  Location: Limeric

The role of the Commissioning, Qualification & Validation Consultant contractor is to implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include but are not limited to the following:

• Generates, executes, reviews qualifications and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Co-ordination with cross function for: interdependent tasks, decision making, timely escalations on quality events/project delays, safety etc.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Capability to work as independent contributor as well as team tasks.
• Well versed with safety practices at site.
• Trains/advises less experienced specialists and technicians.
• Assesses quality system documentation for completeness and accuracy, and dispositions documentation per client SOPs.
• Manages projects and prepares status reports.
• Familiarity with equipment on QC, manufacturing (drug substance – Especially MAbs), AHU, Facilities, utilities.
• Basic familiarity with paperless validation tool like ValGenesis.
• Working to expert level knowledge in21CFR part 11, Computerized system, PLC/HMI/SCADA systems, Audit trail etc.
• Familiarity with deliverables minimum but not limited to: