Purpose
The
Specialist, Engineering, MS&T, Q&V
will be an active member within the cross functional team providing support and guidance and will strive for technical excellence to ensure the success of the Q&V team.
Responsibilities
:
* Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
* Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
* Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
* Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
* Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
* Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.
* Support regulatory audits
* Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities
* Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
* Support, lead or guide others in CQV projects.
Requirements
* Hon. Degree in a Science or Engineering discipline.
* Experience in a GMP environment essential.
* Minimum 5 years' experience in a similar role.
* Demonstrated knowledge in pharmaceutical/biopharmaceutical technical manufacturing operations, with experience of successfully delivering technical projects.
* Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory
* Demonstrated high level of complex problem solving and attention to detail.
* Demonstrated capability of working and collaborating across multiple functional teams.
* Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
* Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels