Samstag, 22. Januar 2022 | Namenstag: Slavomír

Marktplatz | Stellenangebote | Eingetragen am: 20.12.2021
Location: Limbach-Oberfrohna, Saxony - Start: as soon as possible - Full-time


AMETAS medical GmbH was founded in 2017. As a pharmaceutical company from the center of Germany, our focus is on therapeutic needs, the healing of diseases and the relief of symptoms. Our aim is our service obligations towards our patients at a high level of economy, supply security, quality and technical expertise.

To support our team we are looking for an employee (m/f/d) as

Qualified Person (QP).

Start: as soon as possible 
Location: Limbach-Oberfrohna 


Your tasks ...

  • Direct contact person for contract manufacturers in all relevant quality issues (CMO management)
  • Preparation, review and approval of GMP-relevant documents in the area of responsibility (testing and manufacturing instructions/documentation) and ensuring that these comply with the approvals and the relevant EU-GMP guidelines)
  • Performance of the function as a Qualified Person (QP) / batch certification and batch release of the medicinal products manufactured on order and those imported from non-EU countries in accordance with the legal requirements (AMG, AMWHV, EU-GMP Guideline)
  • Active networking through targeted establishment of relationships with international stakeholders, participation in their qualification and monitoring
  • Maintenance of regulatory documents, contact person for regulatory-pharmaceutical issues
  • Preparation, evaluation and approval of Product Quality Reviews
  • Approval / release of suppliers / manufacturers
  • Preparation and accompaniment of supplier audits and inspections by authorities

Your profile ...

  • Approbation as pharmacist and qualification as Qualified person according to § 15 AMG with at least five years of professional experience as a registered QP
  • High degree of accuracy in handling applicable national and international cGMP regulations (EU-GMP, ICH, Annex 16)
  • Application-secure knowledge of GMP regulations regarding manufacturing and quality control on order and the additional requirements for the import of medicinal products from non-EU countries
  • Experience in manufacturing processes for non-sterile oral (solid and liquid) medicinal products
  • Experience with regulatory issues such as approvals, change requests and dossier development
  • Teamwork skills, self-employment, reliability, ability to work under pressure, sense of responsibility as well as communication- and negotiation skills
  • Very structured, thorough, precise way of working
  • Assertiveness and the ability to make independent decisions
  • Very good written and spoken English as well as confident handling of MS Office

We offer ...

  • Flexible working hours
  • A good payment
  • Your cooperation in a young, dynamic, modern, internationally operating company
  • Your own area of responsibility
  • Interesting, varied and challenging tasks in a motivating working environment with high national and international quality standards
  • Promotion of your personal and professional qualifications through needs-based training and further education
  • Company canteen
  • Possibility to work from home on a pro rata basis


Contact ...

We look forward to receiving your application, please only via e-mail!

AMETAS medical GmbH
Christophstraße 6-8 | 09212 Limbach-Oberfrohna
Oliver Förste and Susann Frei, Managing Directors
Tel. 0049 (0)3722 4696288 |

Kontaktní formulář

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AMETAS medical GmbH

Informace o zpracování osobních údajů

1. Pro výběrové řízení na tuto pracovní pozici bude společnost AMETAS medical GmbH, Christophstraße 6-8, 09212 Limbach-Oberfrohna, Deutschland (dále jen "Správce"), zpracovávat Vámi poskytnuté či z veřejných zdrojů získané osobní údaje, a to v souladu s obecným nařízením o ochraně osobních údajů (EU) 2016/679 (dále jen "Nařízení"). 

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Info und Kontakt

AMETAS medical GmbH
Christophstraße 6-8
09212 Limbach-Oberfrohna
0049 (0)3722 4696288

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