Expert in Qualification and Validation
The candidate will be expected to be key member of the Quality Assurance Unit and will be responsible for the qualification and validation activities from quality assurance point of view working closely with the rest of Departments (Technical Services, Production, Quality Control, Maintenance) in order to achieve the proper qualification and/or validation status for Services/Utilities, Equipment, IT Systems, Process, Analytical Methods and Cleaning.
Assessment criteria:
• The candidate will be expected to provide quality assurance oversight.
• Proficiency and capability in managing activities in a fast paced environment is expected.
• At least five years’ experience in qualification and validation activities within the pharmaceutical industry, with a preference within the biopharmaceutical industry.
• Knowledgeable with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP guidelines and GAMP 5
• Experience in the preparation and review of qualification and validation documentation (user requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports) according regulatory expectations.
• Responsible of the Site Validation Master Plan and responsible of all the documentation related to the qualification and validation activities (procedures, protocols and reports, quality system documents …)
• Co-ordinate and prioritize qualification and validation execution activities, including external vendors and internal departments
• Develop and justify the validation approach based on risk and a scientific rational
• Prepare and participate during internal and external audits by answering questions, reviewing qualifications and validations with auditors and providing documentation
• Understand key role validation plays in maintaining compliance and participate in Quality Management System to ensure continuous improvement.
• Review change control documents to evaluate impact on qualified systems and validated processes
• Proven initiative and independent thinking to deliver tasks on time, whilst working in a team environment.
• Ability to work in fast moving environment, maintaining focus on goal and achievement thereof.
• Proficient verbal and written communicator in English and Spanish.
• Team player: ability to interact effectively with teams and customers.
Other requirements:
• Fluent in English.
• Willing to relocate to Northern Spain
Contact Email: rrhh@3pbio.com
WebSite: www.3pbio.com
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