The posting
The Role We now have an excellent opportunity available for a Validation Supervisor within the Technical Operations department at the Quotient Sciences site, Nottingham. As the Validation Supervisor you will be contribute to the success of the business through the effective supervision of the Validation department in the manufacturing area (GMP) and laboratory areas (GLP). The main focus and responsibility is to provide supervision and be the main point of contact for the validation program which directly impacts the regulatory compliance status of the company. You will be responsible for managing and prioritize numerous validation projects, the control of equipment/contractor database, environmental control (viable and non-viable) and equipment procurement/modification within GMP/GLP areas. Main tasks and responsibilities will include:
Perform Impact Analysis for changes in Equipment, Facility Systems, Process, Cleaning Systems and parameters Support FAT, Commissioning / SAT activities of new equipment and new or renovated facilities. Lead and / or supervise IQ/ OQ/ PQ activities of new or existing equipment, and new or renovated facilities. Prepare and execute Validation Protocols (IQ/ OQ/ PQ) for Equipment, Facility Systems, Process and Cleaning in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry best practises. Compile required data and perform data analysis as required per validation protocols. Prepare validation reports. Investigate and troubleshoot problems and determine solutions. Ensure all validation activities are conducted in compliance with cGMP, company policies, safety standards and company SOPs. Be responsible for maintaining and updating the Validation Master Plan as required to remain compliant. Support initiation, actions, and closure of change requests and CAPAs as required. Determine and implement immediate corrective actions as necessary, ensuring the development and implementation of long-term corrective actions by identifying root causes and facilitating the final implementation of the corrective actions. Appraising, evaluating and, where necessary, tender for facilities services provision (GMP and Labs) Acting as the first point of contact for staff to report faults/issues with equipment or facilities in regard to validation within GMP and the labs; and to organise remedial work as appropriate. Ensuring all contractors involved with GMP and the labs are appropriately supervised and that any work performed is aligned with relevant working practices. Perform all other related duties as assigned.
The Candidate The successful candidate must have:
University degree in Engineering or Science and, or relevant equivalent experience. 5 or more years of direct validation experience in pharmaceutical environment and GMP regulations Experience in equipment / process validation, cleaning validation. Knowledge and understanding of pharmaceutical processes and concepts. Knowledge and understanding of GMP and pharmaceutical industry guidelines. Knowledge and understand of Eudralex Volume 4 Annex 15, ISPE guidelines, 21 CFR Part 11 and associated validation standards. Experience in one or more of the following areas is desired: aseptic manufacturing, temperature mapping, solid dose equipment. Previous experience delivering cost effective management of specialist subcontractor services is desired.
Other skills and experiences required are:
Ability to work to a high concentration of work whilst meeting strict and tight deadlines. Ability to manage multiple tasks/issues simultaneously and respond to client demands. Good organizational, presentation and technical writing skills. Confident to work independently with minimal guidance. Ability to work well as part of high functioning team.
This role involves working in a hazardous environment with high requirement to follow safety procedures. Due to the nature of this role, occasionally, you may be required to work outside normal working hours.
