Role Overview:
As a Qualification and Validation Engineer, you will be responsible for developing, maintaining, and executing qualification and validation strategies, plans, protocols, and reports. Working closely with internal and external stakeholders, you will ensure compliance in qualification and validation processes for new and existing equipment, systems, and processes during product introductions, C&Q activities, and throughout the site's requalification program.
Main Responsibilities:
- Maintain and prepare qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices within designated timelines.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA) and the company's quality standards.
- Document deviations, non-conformances, and corrective actions accurately.
- Provide quality oversight for all qualification and validation activities.
- Participate in internal and external audits and inspections, providing relevant documentation and expertise.
- Collaborate with cross-functional teams (engineering, manufacturing, quality control) for effective validation execution.
- Contribute to process improvement initiatives, identifying opportunities to enhance Q&V procedures.
- Provide expert guidance and support on qualification and validation queries.
- Monitor metrics and data related to Q&V activities to identify trends, issues, and manage periodic reviews and re-validation.
Experience & Qualifications:
- Bachelor’s degree in Science (Chemistry, Microbiology, Pharmacy preferred) or Engineering (Chemical, Mechanical, Electrical).
- Proven background in qualification and validation within the pharmaceutical or biotechnology sector.
- Experience planning, executing, and documenting Q&V projects.
- Proficient in drafting and reviewing Q&V protocols, reports, SOPs.
- Deep understanding of regulatory standards (FDA, EMA) governing Q&V.
- Strong project management capabilities; able to handle multiple projects and adhere to deadlines and budgets.
- Skilled in risk assessments, data analysis, and deviation/non-conformance resolution.
- Excellent communication and collaboration abilities.
- Flexible and adaptable approach with strong problem-solving skills.