Lonza is seeking a Senior QA Specialist for its Drug Product Services team in Visp, Switzerland. The role focuses on QA oversight, documentation review, and cross-functional collaboration within a GMP environment.
This position serves as the primary Quality Assurance representative within cross-functional teams, coordinating with Manufacturing, Quality Control, and Engineering to support Drug Product process execution. The specialist acts as the central contact for QA-related inquiries and manufacturing operations issues, ensuring robust quality oversight on the shop floor.
Responsibilities
- Represent the Quality Assurance function within cross-functional teams and maintain coordination with Manufacturing, QC, and Engineering departments.
- Serve as the main point of contact for Drug Product QA inquiries and manufacturing operations issues.
- Provide oversight for Quality Assurance activities on the manufacturing shop floor.
- Evaluate, review, and approve quality records, including deviations, change controls, CAPAs, investigations, and complaints.
- Review and approve GMP-relevant documents such as SOPs, protocols, risk assessments, and manufacturing process descriptions.
- Review and approve executed manufacturing batch records and other GMP documents like logbooks and forms.
- Present Drug Product QA topics during internal audits, customer audits, and regulatory inspections.
- Provide GXP-related trainings to Operations personnel.
- Support continuous improvement programs to establish an effective Quality Management System.
Requirements
- University degree or equivalent in Chemistry, Biology, Biotechnology, or a related field.
- Long-term experience working in the GMP environment of the pharmaceutical industry, preferably in Drug Product.
- Experience working in a QA department is strongly required.
- Fluent English language skills are required.
Nice to have
- German language skills are an advantage.
What the company offers
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits dependant on role and location.
- Relocation assistance is available for eligible candidates and their families.
About the company
Lonza is committed to turning customers' breakthrough ideas into viable therapies. The company values Collaboration, Accountability, Excellence, Passion, and Integrity. It values diversity and is committed to creating an inclusive environment for all employees.
- The company values Collaboration, Accountability, Excellence, Passion, and Integrity.
- The company values diversity and is committed to creating an inclusive environment for all employees.
- The company works to turn customers' breakthrough ideas into viable therapies.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.