Senior Area Quality Owner
vor 1 Monat
We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products
Position summary
As a Senior AQO in the QA Process Parenterals you will join a dynamic team which is responsible for Quality and Compliance guidance, as well as Quality and Aseptic oversight of equipment and premises used for manufacturing in the Business Units Parenterals (compounding and subsequently filling of syringes and vials), Optical Inspection, Device Assembly Packaging and Warehouse departments at the Schaffhausen site.
The focus for our future colleague will be on processes, equipment, and projects in the Parenteral departments. Experience with Compounding processes, Filling processes (isolator technology), Aseptic Process Simulations (APS), Equipment Process Validation (EPV), Smoke studies, Utility processes and Environmental monitoring is key in this role.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity
Your responsibilities
Provide Quality and Compliance guidance to assigned departments and corresponding supporting departments
Perform Quality and Aseptic oversight on the shop floor
Qualification of aseptic operators
Actively contribute to new concepts and projects as well as suggestions for improvement in assigned departments
Proactive risk mitigation
Assess and approve Nonconformances, CAPA investigations, and Corrections/ CAPAs related to utilities, facility, environment and equipment. Quality investigation lead for major non-conformances (CAPA investigations)
Review and approve Protocols, Reports, SOPs/WIs, Change requests (COCs) and other applicable documents
Review and approve GMP critical SAP master data (e.g. manufacturing instructions)
Support ‚customers‘ (Production, Quality Control, Logistics, MSAT, Engineering, etc.) in terms of GMP Compliance
Participate as Subject Matter Expert in Health Authority inspections and audits
Support and guide more junior AQOs and QA specialists in the team
Qualifications Who are you
You have a Bachelor or Master’s Degree in a microbiological, technical or science field
You have proven experience (minimum 5 yrs) in a GMP regulated aseptic Pharma production environment, or experience in a relevant Quality role (minimum 3 yrs)
You demonstrate strong technical and process background in parenteral fill/ finish production
Exceptional knowledge in aseptic processing is key in this role
You know regulatory requirements for sites manufacturing sterile products
You have experience as team or project lead
You are fluent in German and English
If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as need
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