Qualified person (Komárom-Esztergom megye)

Qualified person (Komárom-Esztergom megye)
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We are looking for a Qualified person for our multinational pharmaceutical partner in Komárom-Esztergom County

Your new company

This role will ensure the principles and guidelines of GMP, as stated in regulation OGYI 39/2004 (IV. 26.) FSzCsM and in Directive 2003/94/EC and interpreted in the EU Guide to GMP, have been followed.

Qualified person

Your new role:

  • Review and approval the Outsource, Technical/Quality Agreements,
  • Approves suppliers that are relevant from GMP point of view; Participates in supplier audits,
  • Certifies the finished product batch certification before release for sale in the EC/EEA,
  • Checks that the pharmaceutical products are transported in a proper way as described in relevant regulations,
  • Ensuring qualification and validation documentation complies with GMP. Confirming that the principal manufacturing, packaging and testing processes have been validated,
  • Ensures that the batch records, samples and data loggers’ data and any other data which are applicable for confirming that the batch meets the registered details and is suitable for release,
  • Release of finished product according to the relevant SOP,
  • Reviews and decides on (approves) incident reports, which relate to a product released to market including the risk assessment and the required corrective actions,
  • Supervises and controls the customer and supplier complaints handling process. Decides on the complaints. Keeps contact with the responsible authorities,
  • Takes part in health authority inspections, internal and self-audits. Reviews and approves the reports or notes of audits and inspections.

What you will need to succeed:

  • Sc. in Life Sciences (Pharmacist, Chemical or Biological Engineer),
  • Excellent knowledge of English and Hungarian,
  • At least 7 years of working experience at pharmaceutical company. Experience at a packaging site is preferred,
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
  • Ability to work effectively with the Microsoft suite of Office applications and tools.

What you will get in return:

  • competitive salary
  • excellent benefits
  • an environment conducive to professional growth and advancement.

Location

Komárom-Esztergom Megye

What you need to do now:

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

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