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
8442Hettlingen CH
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 12 36.