QA Process Validation Manager Bioatrium

Vor 4 Tagen

Visp, Schweiz Lonza Vollzeit

Switzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a member of the QA department, the QA Process Validation Manager is responsible under the guidance of the Head of QA Validation to design, plan and oversight process validation activities and studies intended to demonstrate the suitability and robustness of biotechnological manufacturing processes. Thereby, he/she ensures that these validations/studies meet the requirements of internal procedures, customer requirements, regulatory expectations and industry standards.

Key responsibilities:

- Generates process validation/study protocols and reports (incl. hold time studies, mixing studies, resin reuse studies etc.)
- Ensures that internal/external GMP standards and regulatory requirements related to process validation are adhered to in projects
- Participates in or moderates cross-functional Risk Assessments to define the scope of validation/study activities
- Assesses validation data for conformance to protocol acceptance criteria and supports the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures
- Issues, reviews or approves SOPs and project related documents
- Is involved as Subject Matter Expert in the Investigation of Deviations and implementation of CAPAs and Change Requests and the QA review and closure of records
- Represents the Quality Unit in cross-functional teams
- Assists the department in developing programs and SOPs to meet current industry standards, internal and external regulatory requirements
- Key contributor to Annual Product Quality Reviews for Continuous Process Verification
- Participates and supports regulatory inspections and customer audits
- Supports cGMP training programs
- Trains and mentors junior BioAtrium employees to better accomplish and perform in their duties as quality professionals
- Actively supports the Quality culture as a role model

Key requirements:

- Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field
- Experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit or MSAT
- Strong background in cGMPs
- Broad experience in biotechnological manufacturing processes, validation approaches and risk management
- Experience in Technology Transfer and Scale Up
- Sound experience in representing Quality and Compliance in projects
- Good communication skills and experience in interaction with all kind of interfaces within the organization, external customers and with regulatory agencies
- Excellent verbal, written and interpersonal communications skills; Excellent organizational skills
- Strong team orientation and solution oriented
- Fluent in English is Must and German is nice to have

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

**Reference: R52624**:

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