Job Description
QA Validation within the Commissioning & Qualification, role will require involvement in relevant Facility & Utility project validation activities at the Client's manufacturing site.
Responsibilities
- The Consultant will help develop, maintain and continuously improve the qualification and validation activities within key project timelines / deliverables. Will report to QA Leader
Requirements
- Preparation, review and/or approval of Qualification/Validation Documents (e.g. specifications, validation plans/reports, User Requirement Specifications, DQ, IQ, OQ, PQ, PV/CV, RTM, risk assessments, SOPs) in relation to instrument, equipment, facilities, utilities, automated systems and manufacturing processes for the introduction of a new product filling line
- Review and approval of 3rd party generated protocols and reports
- Participate in equipment, process and/or design FMEAs along with SLIA's & SRA.
- Identify current and anticipated requirements for compliant facility & utility systems within the manufacturing environment
- Ensure the archiving and filing of validation documentation associated with the project
- Provide clear communication to all relevant stakeholders where quality related challenges are envisaged and provide quality SME support to proactively drive solutions within a cross functional, customer-orientated environment
- Prepare data/presentations and attend review meetings
- Approval of GMP related documents within the project
- Ensure that current quality standards / regulatory requirements are interpreted appropriately and implemented in line with project remit
- Participate in regulatory / internal audits as relevant
