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Validation Qualification & Processes &Risk Assessments Job Title: Validation Engineer
Location: Cambridge
Job type: 24-Months Fixed Term Contract
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. 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.
Role and responsibilities Leads assigned validation projects ensuring compliant and timely performance, in line with GMP requirements, industry standards (e.g. GAMP5), company procedures and business requirements.
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.
Prepare validations protocols in line with defined and approved validation strategy and company templates.
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.
Supporting change control activities, including performing impact assessments of changes.
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.
What you'll bring Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience.
Formal training in pharmaceutical validation (e.g. GAMP5 or IPSE)
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. 4 Annex 5, Annex 11 and Annex 15, GAMP5.
Good knowledge and experience of Quality Risk Management, including in risk assessment tools e.g. FMEA, HACCP.
Extensive knowledge and experience of various manufacturing processes and equipment for various dosage forms.
Solid understanding of computerized systems validation requirements.
Appropriate understanding of Health & Safety requirements and the impact to validation.
Experience in supporting external audits by customers and competent authorities as subject matter expert.
Excellent technical report writing skills and ability to communicate and interact at all levels of the business and externally.
What we offer in return flexible benefits package
opportunities for learning & development
collaborative, inclusive work environment
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn't just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
About Mundipharma
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.
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Additional Job Description:
Primary Location:
GB Cambridge
Job Posting Date:
2024-04-19
Job Type:
Fixed Term Contract (Fixed Term)