Associate Scientist Cleaning Validation (m/w/d)
Skills: QA,Cleaning Validation
- May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area.
- Ensure cleaning processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including validation plans, protocols, reports, traceability matrix and summary reports.
- Execute validations for cleaning across the site.
- Co-ordinate activities interfacing with multiple sites, departments and external vendors.
- Lead/participate to risk assessments and risk management teams.
- Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
- Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements. Participate to the development and maintenance of the local site procedures.
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
- Participates/lead projects and initiatives and contributes to continuous improvement exercises.
Qualifications & Experience
- Degree in Engineering/Technical discipline or experience equivalent.
- Experience (at least 5 years) in validation required, special focus on cleaning validation for small molecules
- Familiarity with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
- Good communication skills in English and French with stakeholders and outside vendor groups
- Automation knowledge advantageous
- Team player: ability to interact effectively with team and customers
- Proactively identifies problems and recommends solutions