Die Ophtapharm AG ist eine FDA/EU-GMP zertifizierte Produzentin im Pharmabereich (Ophthalmika). An unserem Produktionsstandort in Hettlingen bei Winterthur werden für internationale Märkte qualitativ hochstehende Produkte wie Augentropfen, -salben und -gele aseptisch produziert, abgefüllt und verpackt.
To strengthen our team in Hettlingen, we are looking for a Manager QA Operations to start as soon as possible
Manager QA Operations (m/w) 100%
Ihre Aufgaben
  • Manage key elements of a QA operation including non conformities, complaints, CAPA, change control, risk management, documentation and training
  • Be responsible for manufacturing QA/ QA on the shopfloor, batch record review, PQR/APR 
  • Ensure that compliance and performance processes are continuously measured and improved 
  • Monitor Quality Metrics (Key Performance Indicators) accordingly 
  • Lead inspection readiness activities, represent your department in inspections, customer audits 
  • Manage the compendial Compliance Process 
  • Lead continuous improvement in the area of your responsibility 
  • Stay updated on industry trends, regulations and evolution of Health Authority expectations 
  • Represent the Director Quality in Meetings as needed and when it is requested
Ihr Profil
  • PhD or MSc in Pharmacy, Biology, Microbiology or Chemistry 
  • Demonstrated experience in Operations Quality Assurance 
  • 5-10 years of experience in GMP-regulated environments 
  • Proven experience in sterile drug product manufacturing advantageous 
  • Strong leadership skills and significant experience as line manager 
  • Passionate for performance, drive improvement and innovation 
  • High degree of self-motivation/ proactively and results-oriented way of working 
  • Strong collaboration abilities and excellent communication skills as a point of contact across departments and functions 
  • Analytical and Logical thinker 
  • Strong facilitation and organizational abilities
Ihre Vorteile
  • Dynamic work environment and career opportunities
  • In our company culture we prefer the personnel “You”
  • Parking lots for free and close connection to the public transportation in walking distance
  • Possibility of partial home office (depending on the role)
Arbeitsort
Ophtapharm AG
Riethofstrasse 1
8442 Hettlingen CH
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 12 36.