Job DescriptionValidation Officer
This is an excellent opportunity for someone who has worked in Quality or Manufacturing who has some exposure in Validation and is looking to progress within this field to become a fully trained Validation Engineer.
To plan and execute all validation activities required to ensure compliance the client (a Clinigen Group company) with regard to regulatory and internal expectations. To provide a service to them for the validation of new and existing computerised systems / equipment / facilities / processes, providing visibility of key validation lifecycle requirements.
- To ensure the Site Validation Master Plan (SVMP) is maintained accurately throughout the validation lifecycle and Validation Plans are implemented by working with multi-disciplinary teams across site
- Author or review and approve the development and implementation of Validation Plans
- To support the introduction of new computerised systems, equipment, facilities & processes through the creation of technical documentation including, but not limited to VP, URS, IQ, OQ and PQ
- To play a key role in assessing, reviewing and approving changes that may have an impact on the validation status of the computerised systems, equipment, facilities & processes
- Provide support in achieving / maintaining compliance with EudraLex – Volume 4, ICH, EMA and GAMP guidelines throughout the validation lifecycle
- Ensuring correct operation of change control for procedures and systems where there may be an impact on their validated state
- Providing consistent validation advice and inform validation working party members on changes in compliance or other regulatory expectations relating to validation of computerised systems, equipment, facilities & processes
- Assist the Operations and IT teams with the introduction of new computerised systems or processes from a validation perspective and ensure timely planning and support to their implementation
- Support the IT department with computerised system upgrades and service releases by providing additional validation qualification / testing where required
- Hands on experience of preparing and executing validation documentation in support of the Validation Manager for equipment and facilities such as Manufacturing / Quality Control equipment and Facilities temperature mapping
- Support the creation of business cases to justify Capital Investment
- Training out of new computerised systems, equipment, facilities & processes and procedures to all required personnel
- Work in close collaboration with the development team and business users to ensure that test protocols are fit for purpose by managing and identify risks
- Assist with regulatory inspections, to provide clear explanations for validation activities, protocols, and report.
- BSc (Hons) degree or equivalent in a scientific or engineering discipline
- Good planning, organisational and time management skills along with an ability to make decisions, solve problems, negotiate, influence and communicate effectively with others
- Hands on knowledge and experience of preparing and executing validation documentation throughout the computerised systems, equipment, facilities & processes validation lifecycle.
- Experience of computerised systems such as Enterprise Resource Planning (ERP), Chromatography Data Systems (CDS), QC Sample Manager and Aseptic Compounding systems
- Well-developed verbal, written, numeric and presentation skills (Must be extremely proficient in Microsoft Excel and Microsoft Word)
- Know the Company strategy and make sure what you do on a day to day basis is in line with the strategic objectives
- Ensure the work you do is of a high quality standard and procedures and policies are followed at all times
- Engage in personal professional development and attend mandatory training
- Present the Company in a positive way at all times with internal and external clients, customers and staff.
- Comply with the Company’s HR policies and the Health and Safety policy at all times
- Work flexibly and efficiently in order to meet internal and external customer needs, whilst maintaining the highest possible professional standards
- Bring new ideas and approaches with an open mind
- Maintain confidentiality and security at all times
Please apply ASAP for immediate consideration.