Omega Diagnostics

PLEASE NO AGENCY CONTACT REGARDING THIS ROLE About us Omega Diagnostics Ltd, is a subsidiary of Cambridge Nutritional Sciences Plc, and are pioneers and global leaders in food sensitivity testing. Using advanced diagnostic technology, we enable healthcare professionals and their patients to identify lifestyle and dietary changes that can significantly improve their long-term health and wellbeing. Purpose of the role: To provide specialised validation support and oversight within the Omega Group. The role is for an initial fixed term of 18 months. Main Areas of Responsibility: The planning and execution of validation activities, including equipment, process, and software validation. Supports Internal/External teams in highlighting potentially problematic processes. Provide input to product validation requirements. Set key validation criteria and specifications. Execute periodic validation reviews as required. Utilise statistical analysis to support validation procedures. Evaluate validation impact of proposed equipment or facility improvements. Provide continuous improvement and streamlining of validation procedures. Maintain and update all validation-related documentation throughout the product lifecycle, including FMEA, URS, software validation, risk assessments, HSE, and work instructions. Maintain site validation master plan (VMP)/procedures/processes/templates. Perform all work in a safe manner and in compliance with Omega's procedures and current health, safety, and environment legislation. Assist Quality and Operational teams to assure that the QMS demonstrates compliance with requirements for all products with respect to process and product validation. Carry out in house calibration duties when required Liaise with operational teams and suppliers to ensure maintenance and calibration activities are carried out as per set schedule Knowledge & Skills: Competent in using computer software and IT programmes. Attention to detail Maintain compliance with Health & Safety and Quality policies and procedures Knowledge of electronic document management an advantage Qualifications Essential A degree in a STEM subject and 2 years' experience in a validation role OR 4 years in a validation role in a manufacturing environment Desirable Knowledge of working under a formal quality system such as ISO 9001 or ISO13485 Terms: Working Hours: 37.5hrs per week. Mon-Thur 8:30 - 17:00, Fri 8.30 - 2.30 Potential for flexible working: 3-day office expected Location: Littleport, Ely, Cambridgeshire Salary: £30-35k dependent on experience Benefits: Annual Leave: 25 days plus 9 Bank Holidays - annual leave increases on length of service up to a maximum of 39 days inclusive of Bank Holidays Buy/Sell Leave:purchase or sell up to 5 days annual leave. Purchased leave is a salary sacrifice scheme. Private medical insurance Salary sacrifice pension scheme: up to 5% employer contribution Enhanced company sick pay Enhanced maternity pay Cycle to work scheme Group Life Insurance: 4x salary Employee stock ownership plan Access to free health & wellbeing services 24/7 GP health service Bereavement & Probate Support Referral Programme Friends & Family Discount Scheme Casual Dress Company Events Free fruit & drinks machine To view our company privacy policy please click the below link Job Types: Full-time, Fixed term contract Pay: £30,000.00-£35,000.00 per year Ability to commute/relocate: Littleport: reliably commute or plan to relocate before starting work (required) Work authorisation: United Kingdom (preferred) Work Location: In person