Lonza seeks a Senior QA Specialist for Process Validation in Visp, Switzerland. The role focuses on ensuring compliance for small molecule manufacturing processes through validation, continued process verification, and quality reviews.
The company is looking for a Senior QA Specialist to oversee process validation compliance, primarily for small molecules. The position involves managing validation activities at scale, conducting continued process verification, and leading Product Quality Reviews to ensure manufacturing processes remain validated throughout their lifecycle.
Responsibilities
- Maintain manufacturing processes for APIs and intermediates in a validated state throughout their lifecycle, following company procedures and regulatory standards.
- Develop detailed Validation Master Plans that outline the specific studies needed for process validation.
- Coordinate and lead validation teams, including direct communication with customers.
- Draft validation protocols and reports for studies conducted at manufacturing scale.
- Evaluate the impact of manufacturing changes and deviations on validation status.
- Create and update documented plans for continued process verification.
Requirements
- University degree in Chemistry or a related discipline.
- Extensive experience in small molecules manufacturing, ideally within a validation role.
- Solid understanding of cGMP regulations.
- Comprehensive knowledge of GMP manufacturing processes.
- Proven ability to interact with internal teams, external partners, and regulatory bodies such as Swissmedic and the FDA.
- Fluent English communication skills.
- Professional management of internal and external customer relationships.
Nice to have
What the company offers
- A dynamic work environment with an agile career path.
- An ethical and inclusive workplace culture.
- Performance-based compensation programs.
- Role and location-dependent benefits package.
- Relocation support for eligible candidates and their families.
About the company
Lonza fosters a collaborative and accountable culture driven by excellence, passion, and integrity. The company is dedicated to diversity and strives to maintain an inclusive environment for all employees.
- Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
- Commitment to diversity and an inclusive workplace for all staff.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.