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.
Requirements:
- 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.
Benefits:
- Dynamic work environment and career opportunities.
- Company culture preferring 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).
360-Talents ist eine Full Service Recruitig Plattform. Wir vermitteln die besten Talente zu den besten Stellen. Wir bringen Menschen mit Unternehmen zusammen, die nicht nur fachlich, sondern auch «menschlich» perfekt zueinander passen. Zu diesem Zweck bieten wir wissenschaftlich geprüfte Soft Skills Diagnostik an.
