Quality Assurance Specialist (w/m/o)
We are looking for an experienced and motivated Quality Assurance Specialist (maternity leave cover) , located in Sofia, with a focus on the Swiss market, to join our highly motivated and inspired team at Zentiva.
What Would Be Your Main Responsibilities:
- Perform the Marketing Authorization Holder (MAH) Review on Product Quality Reviews (PQRs) in accordance with Good Manufacturing Practice and local procedures, which consists of the review of the PQR and addition of MAH related data (Quality agreements, complaints, deviations, recalls, risks etc. and variations, post marketing commitments)
We Need You To Have:
- University Degree in pharmacy, biological or chemical science, or other health-related discipline preferred
- Experience in a GMP and GDP-related environment
- Knowledge and active usage of IT tools (TrackWise, eDMS, and /or SAP expertise would be an advantage)
- Fluent in English. Knowledge of German would be an advantage
It is crucial for us to have satisfied employees. Therefore, we can offer you the following:
- Competitive salary;
- Additional benefit package;
- International working environment and a passionate team of professionals;
- Continuous Learning & Development opportunities thanks to our Zentiva Academy;
- A hybrid form of work - on-site & off-site.
Our Recruitment Process:
To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible.
Diversity is a fact. Inclusion is an act @Zentiva
At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.
Join our winning team! Be part of our winning culture! Be Zentiva!
Top Skills
What We Do
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
