This role requires the delivery of validation activities to support manufacturing at the Wales site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers, and regulatory authorities. A member of the validation team who provides direct support to the efficient delivery of the Site Validation Master Plan (SVMP) Schedule.
- Responsible for the completion of assigned validation activities on time in accordance with the SVMP schedule.
- Generation of related project documentation and protocols for installation, operation and performance qualifications, Validation plans and reports
- Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
- To follow all Standard Operating Procedures (SOP’s), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.
- To document all EHS incidents and cGMP events to agreed timelines using the required business systems.
- To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.
- Liaise with external contractors to arrange the completion of PPM activities, and the subsequent administration of PPM to closure.
- Supports the administration requirements for Validation documentation during Regulatory Inspections.
- Supports internal audits where required, taking responsibility for the closure of assigned actions in a timely manner.
- Continuously look to support continuous validation improvement activities.
- Support other departmental activities as requested by department management or designate.
- Ensure that all interactions and engagements are carried out in accordance with Company DNA and that all work is accomplished with quality and in accordance with the Company values.
- Carry out other reasonable tasks as required by the Line Manager.
Education and Experience
- Educated to GCSE – HND/C standard in a relevant Science subject and / or experience of working in a manufacturing environment that employs a quality system (cGMP, ISO9001).
- Understanding or can show awareness of cGMP and EHS practices.
- An understanding of Lean Manufacturing principles and the application of 5S desirable.
- Computer literate.
Skills and Attributes
- High standards of attention to detail and the desire to see tasks through to completion.
- Must have good listening skills and be able to follow instructions and guidance.
- Must be able to work as part of a team and demonstrate initiative, when required.
- Must be able to train others and deliver clear instruction, when required.
- Must have a flexible, positive, and willing attitude always.
Applications are encouraged from all sections of the community.