QA Manager Chemical Small Scale
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
We are currently looking for a QA Manager Chemical Small Scale for the expansion of our team here at our site in Visp.
- Responsible for adherence with the quality agreement provisions
- Accountable to ensure all deviations are appropriately investigated and recorded
- Responsible to drive CAPA items to complete and timely completion
- Direct the investigations of customer product complaints and assures the completion of the appropriate documentation
- Perform assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required
- Ensure an efficient cGMP compliant life cycle management of all products manufactured
- Has the authority to make quality decisions for the project in internal and external meetings
- Execute quality compliance activities:
- Compiling, verifying and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
- Ensure that documents are correct, adhere to information filed to the authorities and that revisions/reviews are done in a timely manner
- Assess project-specific risks and internal adherence to cGMP by identifying areas of non-compliance through risk assessments and internal & external audits; SME for clients audits and participate in regulatory inspections of health authorities
- Single client contact point for all project related quality requests
- Bachelor or Master's degree in Chemistry, Biotechnology, Life Science or related field
- Preferably some prior QA experience in the pharmaceutical industry
- General knowledge of manufacturing processes and analytical methods
- Subject matter expertise in cGMP compliant manufacturing
- Auditing experience, auditor certification is an asset
- Ability to oversee project execution to identify non-compliance from quality standards
- Able to work autonomously with established procedures and only receiving some direction on projects
- Excellent verbal, written and interpersonal communications skills
- Excellent organizational skills
- Strong problem-solving and attention to quality is a must
- Requires independent decision making regarding quality and compliance
- Ability to work in partnership as an active member of a team and/or cross functional working groups
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment
- Ability to align cross-functional stakeholders to ensure cGMP compliant project execution
- Provide exceptional customer service by developing excellent working relationships with clients both external and internal
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.