QA Specialist conducting client evaluations and developing service plans in the home care sector. Responsible for supervising staff and ensuring compliance with regulations, with duties involving field visits and documentation.
UH
Hybrid Senior QA Specialist, Cleaning Validation
Posted 2 months ago
About the role
- Senior QA Specialist at Lonza ensuring compliance during cleaning validation processes. Supports validation teams and oversees documentation for audits and regulatory compliance in life sciences.
Responsibilities
- Support the validation specialists during the whole lifetime of the cleaning validation to ensure compliance with Lonza procedures and regulatory guidance
- QA Review and approval of validation documents (Soil characterization studies, risk assessments/ validation protocols and reports).
- Support Cleaning Development teams during the development phase.
- Review and approve Cleaning strategy paper, Swab position assessments etc
- QA Review and approval of Annual cleaning review reports
- Ensure the validation procedures are consistently implemented and further developed at Lonza Visp
- Participation in audits and inspections
Requirements
- Master degree or PhD in Chemistry/ Biotechnology or any related field
- Significant experience in the area of biopharmaceutical manufacturing, preferably in a validation function as well as strong background in cGMP
- Broad knowledge of manufacturing processes in GMP environment
- Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
- Fluency in English language required, good German language skills would be an advantage.
Benefits
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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