Qualification & Validation Specialist

Job title: Qualification & Validation Specialist

• Location: Csanyikvölgy, Miskolc
• Hiring Manager: Balázs Kepiro
• Job Type: Fixed term, full-time

Main Accountabilities

·         Quality oversight of qualification and validation tasks in his/her area

·         Preparing and reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre-defined timelines.

·         Ensuring proper documentation of deviations, non-conformances, and corrective actions

·         Ensuring proper evaluation (validation expertise) of change controls

·         Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards

·         Participating in internal and external audits and inspections, providing necessary documentation and support

·         Cooperating with cross-functional teams, including engineering, manufacturing, and quality control, to ensure smooth execution of validation activities

·         Providing qualification and validation expertise when requested

·         Identifying opportunities for improving qualification and validation processes and contributing to continuous improvement initiatives.

Key roles (D,A,I)

·         Review and approve the qualification and validation quality documents (A)

·         Prepare internal and external audits and HA inspections related to validation and qualification by identifying Q&V risks (A) and proposing mitigation plan (A)

·         Support other departments to ensure smooth validation processes (A)

Expected Experience

·         Experience in validation and qualification activities within the pharmaceutical or biotechnology industry

·         Experience in managing qualification and validation projects, including planning, execution, and documentation

Expected Technical skills

·         Proficiency in preparing and reviewing qualification and validation documentation, including protocols, reports, and standard operating procedures (SOPs)

·         Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA) related to validation and qualification

·         Ability to manage multiple validation projects simultaneously, ensuring they are completed on time and within budget

·         Expertise in conducting risk assessments, analyzing validation data, and resolving deviations and non-conformances

·         Excellent communication skills to effectively collaborate with cross-functional teams

Language

Fluent in English (written and spoken)

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Why choose us?

· Join a leading pharmaceutical company and contribute to improving health outcomes worldwide.

· Be part of a company at the forefront of medical research and breakthrough therapies.

· Thrive in an environment that values diversity of thought and background.

· Work closely with global and local teams, gaining exposure to various aspects of the pharmaceutical business.

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