
Validation Team Leader
7 hours ago
We are seeking a talented and experienced Validation Lead to join our team. As a key member of our validation team, you will be responsible for leading the development and implementation of validation strategies, ensuring compliance with regulatory requirements.
Your primary objective will be to maintain high-quality standards in all processes, including GxP, GLP, GCP, and GMP. You will work closely with cross-functional teams to ensure validation activities align with project goals.
Key Responsibilities:- Lead the validation team in ensuring all processes adhere to GxP standards
- Develop and implement validation strategies to meet regulatory and industry standards
- Supervise and mentor validation engineers/specialists on GxP, validation testing, and CSV best practices
- Oversee the development, review, and approval of CSV documentation, including validation plans, protocols, reports, and risk assessments
- Stay abreast of regulatory changes and ensure all processes, systems, and documentation comply with current regulations
To be successful in this role, you will need:
Education: Bachelor's or Master's degree in a relevant field
Experience: Minimum of 7 years of experience with a focus on GxP, validation testing, and CSV
Skillset: Strong analytical and problem-solving skills, excellent communication and collaboration abilities, ability to lead, mentor, and motivate a team
Software Knowledge: Familiarity with various validation methodologies and tools, hands-on experience with eQMS, eTMF, RIM, CTMS, Argus, RAVE EDC or similar systems
Benefits:This is an exciting opportunity to work with a dynamic team and contribute to the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Others:In addition to the above, we value diversity, equity, and inclusion in the workplace and are committed to creating a culture that supports the well-being and success of all employees.
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