Job Title: Process Quality Specialist
**Job Description**
We are seeking an experienced Process Quality Specialist to join our team. As a key member of the Technical Compliance Team, you will be responsible for all activities required to support project commissioning and qualification.
**Responsibilities:**
- Provide input into all aspects of C&Q i.e., from design through to commissioning and qualification completion.
- Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
- Prepare C&Q protocols as required (e.g., URS's / SRS's, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
- Review and approve documents prepared by contractor organisations (e.g., vendor SAT's, FAT's, commissioning protocols, project change controls/notifications).
- Execute C&Q protocols as required.
- Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols/reports.
- Complete activities/deliverables in accordance with each project's site change control required deliverables (from a C&Q perspective).
- Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
**Required Skills and Qualifications:**
- Third level degree and relevant experience.
- Minimum 5+ years' experience in the Pharmaceutical (API) Industry.
- Experience of commissioning and qualifying some of the following systems: Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean/gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
- Experience preparing and executing commissioning and qualification protocols and reports.
- Experience in cGMP regulated environment.
- Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.
- Knowledge and experience of Project Delivery Processes (PDP).
- Knowledge and experience of current Good Engineering Practices (GEP).
- Experience with use of ABB Industrial IT control systems.
- Experience of Pharmaceutical facility local and controlling instrumentation.
- Experience of working within a Technical Compliance/Project team in a multinational corporate environment.
- Experience of ASTM 2500 and/or Risk Based Qualification approach.
**Benefits:**
As a valued member of our team, you will have the opportunity to work on exciting projects, develop your skills and expertise, and contribute to the success of our organisation.
**How to Apply:**
Please submit an updated CV to [apply link].