Qualified Person (QP)/Quality Specialist - Dr. Max Own Label
Dr. Max is the leading pharmacy chain in Europe. In every country where we are active, Dr. Max is dedicated to improving the level of health care available by guaranteeing access to a broad assortment of medicines and pharmacy services. Our pharmacies are currently present in 6 countries (Czech Republic, Slovakia, Poland, Romania, Serbia, Italy) with great expansion plans for the near future. Dr. Max Own Label provides a wide range of pharmaceutical products sold exclusively in Dr. Max pharmacies in all our countries. It includes products such as Gx, OTC, food supplements, cosmetics, medical devices etc. Join our growing team at a leading generic pharmaceutical company where quality, innovation, and reliability drive everything we do.
Required education: University Degree
Required languages: Native Czech/Slovak, English (advanced)
Employment form: Full-time work
- Play a pivotal role in ensuring compliance, improving processes, and mentoring others in a rapidly expanding Quality Department
- Ensure full compliance with relevant EU and Czech legislation, including but not limited to:
- Directive 2001/83/EC (as amended)
- Act No. 378/2007 Coll. (as amended)
- Decree No. 229/2008 Coll. (as amended)
- Ph.Eur. (European Pharmacopoeia)
- EudraLex – Volume 4 (Good Manufacturing Practice, GMP Guidelines)
- Overseeing the importation of medicinal products from third countries and ensuring compliance with EU certification and distribution regulations within the EU
- Collaborate in the introduction and ongoing management of the Quality Management System (QMS) and Good X Practice (GxP) standards
- Ensure that every batch of medicinal products is manufactured and tested in accordance with EU/CZ legislation, marketing authorization dossiers, and the specific marketing authorization for the product
- Certify and maintain a register confirming that each production batch complies with the requirements, ensuring the register is up-to-date and archived for at least five years
- Reports significant quality issues to company management without delay and communicates with competent authorities when required
- University degree in Life Sciences (Pharmacy, Chemistry, Life Science or related fields)
- Previous relevant experience in quality assurance within the pharmaceutical industry, with expertise in GMP
- Qualified Person Certification: Meets the requirements outlined in Article 49, paragraphs 2 and 3 of Directive 2001/83/EC
- Proven ability to analyse and resolve complex quality issues with a proactive and strategic approach
- Good communication, negotiation and organizational abilities
- Native Czech/Slovak speaker and advanced level of English
- Working for the largest pharma retail company in Europe
- A company with a meaningful purpose, an outstanding customer value proposition within an industry offering a resilient, non-cyclical growth pattern
- Global-level job within headquarters with a group-wide impact
- Space for professional growth within a growing organization
- Attractive financial compensation (salary and yearly bonus)
- Flexible working hours, possibility of 1 day/week home office
- 5 weeks of holidays, discount in Dr. Max pharmacies, meal allowance, Multisport card fully covered by employer, public transport contribution, sabbatical leave, pension insurance contribution, referral bonus etc.
If you are interested in this opportunity, please send your CV to groupHR@drmax.eu
Dr. Max Group is a European pharmaceutical concern owned by Penta, an investment group established in 1994, operating primarily in the countries of Central and Eastern Europe. Their offices are located in Prague, Bratislava, Warsaw, and Limassol. The business areas of Penta Investments include long-term investing in healthcare, financial services, retail, manufacturing, media and real estate development. The companies of Penta’s portfolio employ more than 43,000 people, with more than 22,000 professionals working in healthcare. The group’s assets value reached €14 billion in 2022.