Informations:

Company Name:

Mylan Hungary Kft.

Location:

Komárom

Sectors:

  • Engineer
  • Chemical Engineer
  • Healthcare, Pharmaceutical Industry
  • Pharmacist
  • Quality Assurance

How to apply?

To apply, please send your hungarian&english CV with your motivation letter with the „jelentkezem” button underneath.

Why Mylan?
Fore more information, please visit www.mylan.com

QA&QC support manager

Mylan is one of the world's leading generics and specialty pharmaceutical companies, providing products to customers in approximately 150 countries and territories. The Komarom operation is a key strategic site in the Mylan plant network and in the European Union.

At the Komarom sites we have four key roles. First is the packaging of >90% of all blister packs sold in the EU. Second is the analytical testing and release of all solid dosage forms sold in the EU that are both packaged in Hungary and that are manufactured outside the EU. Third is the distribution of c96M packs that the site produces. Fourth, the site houses the Regional Quality Assurance organisation and is a centre of excellence. The site has more than doubled in the last year alone. The number of people employed has more than doubled from c210 to 440 people in 2015. In 2015 the site produced 90M packs. The operations are best in class and working conditions are excellent.

As Mylan continues to grow opportunity for development and advancement abounds both within Hungary and within Mylan around the world.

Task:

  • Provides support for Quality Control, Quality Assurance activities, release of incoming materials, and for the assessment and approval of supplier and local investigations.
  • Ensures proper and timely approvals of all Quality Control investigations requiring QA approval in accordance with relevant SOPs take place.
  • Supports the evaluation, review of suppliers’ investigations and ensures their proper and timely approvals.
  • Responsible for review and approval of investigations related to activities of Quality Control Department (QC IR), and their corrective and preventive actions
  • Provides timely data and ensures that the Quality Council and Quality Management System review indicators are maintained at appropriate levels and participates in related meetings.
  • Supports the review of the Quality Control Department’s SOPs and is responsible for their approval as subject matter expert..
  • Responsible for the review of Certificate of Analysis of the Active Pharmaceutical Ingredients and their availability to the Qualified Persons.
  • Responsible for the review of Certificate of Analysis of the Finish Product and their availability to the Qualified Persons for release.
  • Responsible for review and timely approval of the documents regarding to the analytical method transfers (protocols, reports) and transit trials (protocols, reports)
  • Provides support for the trainings of Quality and other function in Laboratory investigations.
  • Provides assistance in the training and mentoring of other members of staff in all aspects of GMP and other areas, as appropriate.
  • Participates in internal audits and agency inspections.

Expectation:

  • Educated to degree level preferably in the field of Pharmacologist, Chemist, Chemical Engineer
  • 7 years experience in pharmaceutical drug product QA and QC position in a wide portfolio of dosage forms (preferably to include oral solid dose).
  • Excellent knowledge of English and Hungarian both in written and verbal
  • Have a clear understanding of the practical application of the rules of pharmaceutical GMP.
  • Experience delivering complex projects on time in budget.

    To apply, please send your hungarian&english CV with your motivation letter with the „jelentkezem” button underneath