123pracovat

Pracovní nabídka

What will be your responsibilities?

• 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:

1. Directive 2001/83/EC (as amended)
2. Act No. 378/2007 Coll. (as amended)
3. Decree No. 229/2008 Coll. (as amended)
4. Ph.Eur. (European Pharmacopoeia)
5. 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

What do we expect from you?

• 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

What do we offer?

• 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.