Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
In this role you will own all quality related responsibilities for the daily qualification activities of facilities/equipment/systems related to the cGMP manufacture of pharmaceutical drug products (DP).
What you will get:An agile career and a dynamic work culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Visp: https://bit.ly/3wjkoFi
What you will do:Compile, review and release Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, etc.)
Perform assessments and approvals of technical change requests and their relevance to the qualified state of equipment, utilities and systems
Support and approve quality risk analysis (e.g. FMEA)
Ensure relevant deviations are appropriately investigated and recorded in Deviation Reports
Responsible to drive CAPA and Effectiveness Checks items to completion and timely closing
Confirm the qualified state of facilities, equipment and systems during their life cycles by ensuring periodic reviews or periodic re-qualifications
Ensure that documents are correct and adhere to SOPs and customer’s requirement
Represent specific areas as Subject Matter Expert (SME) and provide guidance’s and recommendations in these areas to internal customers
Lead or support specific projects in his area of SME to develop further the quality standards
Write or revise SOPs in his area of SME and acts as Owner of such documents
Enhance the quality knowledge by following the quality standards and by visiting specific training courses/congresses
Identify areas of non-compliance through internal audits or other observations
Represent qualification topics during customer audits and regulatory inspections
Support cGMP training programs to ensure staff is being trained
Train and mentor junior employees to better accomplish and perform in their duties as quality professionals
Academic degree in Engineering/ Chemistry/ Biotechnology or related field
Significant experience in the pharmaceutical Drug Product industry, ideally in a QA role
Good understanding of the applicable cGMP regulations
General knowledge of engineering and manufacturing processes
Subject matter expertise in cGMP compliant qualification
Able to work autonomously with established procedures
Excellent verbal, written and interpersonal communications skills in German AND English required
Ability to pay attention to accuracy and detail
Ability to work in partnership as an active member of a team and/or cross functional working groups
Strong individual contributor and decision maker
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Skills Required
- Academic degree in Engineering, Chemistry, Biotechnology or related field
- Significant experience in the pharmaceutical Drug Product industry
- Experience in a QA role
- Good understanding of applicable cGMP regulations
- Subject matter expertise in cGMP compliant qualification (facilities/equipment/systems)
- General knowledge of engineering and manufacturing processes
- Ability to work autonomously with established procedures
- Excellent verbal, written and interpersonal communication skills in German and English
- High attention to accuracy and detail
- Ability to work in partnership as part of a team and cross-functional groups
- Strong individual contributor and decision-maker
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
