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MS&T Validation Specialist
vor 3 Monaten
Our client, a leading biopharmaceutical company, is seeking a highly skilled Validation Senior Scientist to join their team at their commercial manufacturing site. As a subject matter expert in validation processes, you will ensure that products and processes meet regulatory requirements and quality standards.
Key Responsibilities:
- Develop and implement site process validation and revalidation strategies to meet cGMP and quality requirements.
- Collaborate with cross-functional teams to define interfaces for equipment qualification, system qualification, and analytical method validation.
- Establish and maintain the Validation Master Plan for process validation.
- Participate in transfers and launches, and align with technical development for new products.
- Author or review routine validation protocols and reports, associated change controls, and support execution at the shop floor.
- Lead and drive investigations for validation-related matters and implement corrective and preventive actions.
- Contribute to all relevant audit inspections and ensure inspection readiness for the site.
- Initiate, drive, and implement continuous improvement initiatives to optimize processes and enhance product performance.
Requirements:
- Bachelor's degree in Engineering, Chemistry, Pharmacy, or Natural Science.
- Minimum 4-6 years of experience in the pharmaceutical industry.
- Strong problem-solving skills, strong verbal and written communication skills.
- Project and change management experience, with experience in Product Life Cycle Management.
- Experience with Health Authority inspections, including preparation, process, presentations, and responses drafting.
About gloor&lang AG:
gloor&lang AG is a leading consulting firm specializing in life science talent acquisition. We provide expert recruitment services to the pharmaceutical, biotechnology, and medical device industries.
