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Parttime Engineer - Cambridge, Cambridgeshire, United Kingdom - Mundipharma
Description
Validation Qualification & Processes &Risk AssessmentsJob type: 24-Months Fixed Term Contract
We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Validation Engineer needs to provide Validation leadership, Specialist Knowledge and Executes validation projects, ensuring these are completed in line with GMP requirements, industry standards, company procedures and business requirements, collaborating with key stakeholders for the design, preparation, completion and final reporting.
Leads assigned validation projects ensuring compliant and timely performance, in line with GMP requirements, industry standards (e.g.Define in collaboration with key stakeholders of the validation strategy following a risk-based approach as per ICH Q9 and ensuring regulatory and GMP requirements are met.
Management of nonconformances and resolution of issues with key stakeholders and/or the Qualified Person as appropriate.Input into the User Requirements Specification (URS) and co-oversight of Factory and Site Acceptance Testing (FAT/SAT).
Coordination of the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) as defined in the respective validation protocols.
Performing or supporting risk assessments (e.g. FMEA) and the identification of risk control measures.Completing on-time all assigned Quality System commitments (including Change Control actions, CAPA, training, document periodic reviews).
Supporting internal and external audits as validation SME and validation project owner.
Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience.
Formal training in pharmaceutical validation (e.g. Practical experience in QA and/or Validation roles within the Pharmaceutical and/or Medical Devices Industry.
Good knowledge and application of GMP and Pharmaceutical regulatory requirements.
Breadth and depth of knowledge and application of pharmaceutical validation requirements, including Eudralex Vol. Good knowledge and experience of Quality Risk Management, including in risk assessment tools e.g. Extensive knowledge and experience of various manufacturing processes and equipment for various dosage forms.
Excellent technical report writing skills and ability to communicate and interact at all levels of the business and externally.
flexible benefits packageDiversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. Join our talent pool
If you're not sure this role is right for you but you're keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
Fixed Term Contract (Fixed Term)
