Oversee all aspects of the Validation Program to ensure that validation processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC and other appropriate regulations and standards. This includes site safety requirements and applicable Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Management and development of robust and compliant validation processes and procedures to include maintenance, development and execution of the site Validation Master Plan and Data Integrity Governance Plan.
- Provide support and leadership to ensure compliance with both software and hardware validation regulatory requirements including 21 CFR parts 11, Annex 15 (Eudralex), GAMP and other guidance documents, as appropriate to the business needs.
- Provide validation support, resource, guidance and expertise to projects to on validation requirements, including the development of required Validation Plans, preparation and execution of validation impact assessments, system risk assessments, protocols and reports.
- Provide validation resource, guidance and expertise in support of regulatory submissions.
- Provide validation guidance and expertise for investigation of failures and participate in CAPA and continuous improvement initiatives
- Development of cross functional and collaborative relationships within the facility.
DESIRABLE SKILLS / QUALIFICATIONS
- Bachelor’s Degree in a quality or science related discipline (chemistry, biology, medical technology) or equivalent professional training.
- Five (5) years’ experience in a drug manufacturing, medical device, biologics, or related industry.
- Experience of supervising and motivating personnel, managing by objectives and conducting personnel appraisals/performance reviews
- Previous experience should demonstrate expertise in, cGMP, FDA regulations, SOP development, as well as an understanding of Validation and Data Integrity Principles.
- Six Sigma Qualified (Green Belt or above)
- Strong analytical and problem solving skills, including presentation of results into meaningful reports
- Competent in the use IT technology, such as Microsoft Word, Excel and PowerPoint.
- Good communication skills (written and verbal) with the ability to collaborate and present at all levels and functions of the organization