You oversee GDP and quality activities, ensuring compliance with regulations and standards. Your role involves managing quality issues, conducting audits, and providing training to uphold operational excellence.
Anforderungen
- •Team player and sociable personality
- •University degree (Master), preferably in Pharmacy
- •3+ years’ experience in QA
- •High quality awareness and in-depth knowledge
- •Excel with self-initiative and organizational talent
- •Experience in cross-functional teams
- •GMP/GDP knowledge
- •Proficient in German and English
Deine Aufgaben
- •Develop and drive excellence in GDP and Quality activities.
- •Ensure compliance with national regulations and AstraZeneca standards.
- •Manage quality complaints and product returns.
- •Execute product recalls in coordination with health authorities.
- •Qualify suppliers and customers.
- •Conduct GDP inspections with the Responsible Person.
- •Perform internal audits with the Responsible Person.
- •Act as a GDP expert and conduct self-inspections.
- •Handle deviations and CAPAs, including change and risk management.
- •Create and update GDP SOPs.
- •Manage and approve Quality Agreements with manufacturers and service providers.
- •Conduct quarterly management reviews with the Responsible Person.
- •Provide GMP and GDP training with the Responsible Person.
Deine Vorteile
Great team environment
Starting salary from €65,954
Bonus payments and company car
Extensive social benefits
Diverse development opportunities
International climate-neutral company
Original Beschreibung
# Marketing Company Operations Quality (MCOQ) Specialist - (f/m/d)
**Austria - Vienna** | **Full time**
**Quality Assurance (QA) Manager / Deputy Responsible Person (RP)**
Location: Vienna, Austria
Type: Permanent
**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 Austria and apply entrepreneurial thinking that drives the company forward.
**Accountabilities:**
Your main responsibilities include:
* Develop, support and drive excellence in GDP and Quality activities in order to meet the AZ objectives and to maintain the local Licence to Operate (LTO) at MC Austria.
* manage the implementation of, and adherence to, national regulations of the authorities and AstraZeneca Standard for Good Manufacturing Practices and Good Distribution Practices, in the Marketing Company
* Handle quality complaints and returns.
* Perform recalls in alignment with national health authority and global AstraZeneca functions.
* Qualify suppliers and customers.
* Responsible for GDP inspections together with the Responsible Person
* Responsible for internal AstraZeneca audits together with the Responsible Person
* 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.
* Management and approval of Quality Agreements with the manufacturers and with service providers.
* Conduct quarterly management reviews together with the Responsible Person
* Responsible for GMP / GDP trainings together with the Responsible Person
**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, hospital Pharmacy or similar (e.g. Medical Devices).
* High quality awareness, in-depth knowledge of respective regulations
* 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
**We offer:**
* A great team in a lively and diverse environment
* A starting salary from €65,954 gross per year. Depending on qualifications and experience, overpayment is possible.
* Participation in company success through bonus payments, as well as a company car and company mobile phone
* Extensive social benefits, such as a company pension and supplementary insurance
* Diverse development opportunities
* An international pharmaceutical company with the ambition to be climate neutral by 2025
**Date Posted**
23-Jun-2025
**Closing Date**
06-Jul-2025
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.