Responsable Assurance Qualité (AQ) / Personne Responsable Adjointe (PR)

Join our QA team at AstraZeneca in Baar, Switzerland, where you'll ensure quality oversight. Enjoy a dynamic work environment with opportunities for growth.

Tasks

• Release medicinal products and devices for the Swiss market.
• Ensure compliance with GMP and GDP regulations in manufacturing.
• Handle quality complaints and oversee product recalls.

Quality Assurance (QA) Manager / Deputy Responsible Person (RP)

Location: Baar, Switzerland (hybrid)

Introduction to role

Join our QA team at AstraZeneca, where you will ensure quality oversight, maintain our license to operate, and foster an environment of continuous improvement in collaboration with our local and global functions. This is your chance to shape the future of AstraZeneca in Switzerland and apply entrepreneurial thinking that drives the company forward.

Accountabilities

As deputy Responsible Person (RP/FvP) your main responsibilities include:

• Release the medicinal products, the medical devices and the demo materials for the Swiss market.
• Ensure that the medicinal products and the medical devices are manufactured, transported and stored in accordance with the GMP / GDP regulations.
• Handle quality complaints and returns.
• Report quality defects to Swissmedic
• Perform recalls in alignment with Swissmedic and global AstraZeneca functions.
• Qualify suppliers and customers.
• Responsible for GDP inspections in Switzerland.
• Responsible for internal AstraZeneca audits
• Act as a GDP expert and perform self-inspections, handle deviations and CAPAs. Change management and risk management are also part of your tasks.
• Create and revise GDP SOPs.
• Perform Product Quality Report reviews.
• Management and approval of Quality Agreements with the manufacturers and with service providers.
• Conduct quarterly management reviews
• Responsible for GMP / GDP trainings.

Crucial Skills/Experience

• Team player and sociable personality
• University degree (Master), preferably in Pharmacy, Chemistry, Biology or similar.
• 3+ years’ experience in QA in the Pharmaceutical Industry
• High quality awareness, in-depth knowledge of Swiss legislation on Medicinal Products
• Excel with self-initiative, collaborative skills, organizational talent and well-structured way of working.
• Experience in cross-functional teams
• GMP/GDP knowledge
• Proficient in German and English, French an advantage

What we offer

• Potential for growth and development, with opportunities to take on increased responsibilities over time.
• A motivated and dynamic team with the support of a strong international company
• Independent work with a high level of personal responsibility
• Competitive compensation
• Attractive and flexible employment conditions

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.