Senior Validation Expert Haarlem

The company
This company is a global leader in the development and production of affordable generic medicines and innovative specialty pharmaceuticals. With a rich history spanning over a century, this company is dedicated to enhancing health and improving the lives of patients worldwide. By leveraging cutting-edge research, advanced technology, and a commitment to quality, this company delivers a wide range of high-quality generic and specialty medications across various therapeutic areas.

Role Description
In this role you’ll spearhead critical equipment qualification activities and ensure compliance with regulatory standards. Bring your expertise to collaborate with cross-functional teams, drive excellence in validation practices, and mentor emerging talent in a stimulating and rewarding environment.

Responsibilities
-Take charge of and actively engage in ensuring equipment meets rigorous standards through installation, operation, and performance qualifications
-Assist in implementing validation protocols/plans for the validation or re-qualification of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, and conduct smoke studies/air flow visualization studies
-Provide technical expertise and guidance on validation-related issues to project teams and stakeholders.
-Conduct risk assessments and impact analyses related to validation activities and propose appropriate mitigation strategies.
-Guarantee compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) throughout the validation procedures.

Requirements
-Bachelor’s or higher degree in a relevant scientific or engineering discipline.
-Minimum 5 years of validation/CQV experience within the pharmaceutical industry, possessing extensive expertise in GMP, including V-Model & SDLC methodologies.
-Strong analytical, problem-solving, organizational, and project management capabilities.

Other information
Apply to our vacancy for more information. looking forward to hearing from you!