Description
Senior QA Engineering Projects
Role Description/Responsibilities
- Preparation and update of Validation strategy documents as necessary,
- Quality approval for change requests,
- Preparation and update of applicable PFMEA's,
- Review and approval of significant changes relating to new equipment/facilities updates and identification of critical parameters to be validated/verified,
- Review and approval of Validation protocols for transferred/new equipment and processes. IQ/OQ/PQ/PV,
- Provide day to day direction on quality assurance issues within the project team,
Review and approval of validation protocols and procedures for changes/updates to process manufacturing lines, - Control of equipment and product during validation and release of product post validation.
- Raise and follow through on CAPA's and NC's resulting from Equipment transfer validations.
- Work in partnership with Engineering Transfer team to ensure quality and achieve improvement initiatives within the transfer project
Educational Qualifications Required
- Third level qualification, ideally in Engineering or Science.
- 5+ years experience in Healthcare or Electronics industry.
- Strong analytical skills with good knowledge of process control systems.
- Knowledge of Six Sigma and Lean tools
- Self motivated with ability to handle multiple priorities
- Must be familiar with the regulatory requirements of the FDA and/or ISO.
- Equipment, process and facilities validation experience an advantage
- Decisive, good communicator, self-motivated, have record of achievement and be a good team member.
- Validation experience for processes and facilities is a necessity for this role