Head of Quality Assurance

Azienda:
Human Value
Dettagli annuncio
DATA DI PUBBLICAZIONE
17/06/2022
LUOGO
Estero

SETTORE
Chimico, farmaceutico

CATEGORIA - RUOLO
Produzione/Responsabile qualità

ANNI DI ESPERIENZA
da 5 a 10 anni

CONTRATTO
Tempo indeterminato

The Context

Our Client is leading pharmaceutical multinational group, headquartered in Italy, with companies operating all around the world, including the US, researching and developing, manufacturing and commercializing innovative drugs and diagnostic solutions with state of the art technologies and focusing on unmet therapeutic needs, making the difference to the life of patients.
For one of its key manufacturing plants in Germany (Dresden), active in the large-scale production of oral solids, we are looking for the:
Head of Quality Assurance 

Place of work: Germany (Dresden)
 

The Position

He/She will be in charge of managing the Quality Assurance Dept. (12 GMP Quality Assurance Officers), reporting in solid line to the Quality Unit Director and in dotted line to the Corporate Quality Director, in the Group Headquarters located in Italy.
It is a challenging role, expected to bring innovation and fresh approaches to the department, with perspectives of further growth within the wide Company organization.
Main Responsibilities:
  • Implementation, maintenance and further development of a functioning quality assurance system in accordance with the GMP requirements; according to EC GMP Guideline, the German Medicines Act (AMG), the German Medicines and Active Pharmaceutical Ingredients Regulation (AMWHV), other national and international regulations and according to customer requirements;
  • Guidance and coordination of the work of the subordinate GMP officers;
  • Carry out notification and reporting duties of the pharmaceutical manufacturer to the authorities in the event of changes relevant to monitoring, personnel and structural or process-related changes;
  • Apply for the issuance of official certificates (e.g. import, GMP certificates);
  • Organize and control internal company measures in preparation for inspections by authorities or customers, derive measures from the inspections, develop and discuss solutions with the specialist departments and control their implementation;
  • Approve self-inspection protocols and resulting CAPA measures as head of quality assurance;
  • Draw up and update quality assurance documents, in particular the quality management manual, site master file, procedural instructions;
  • Review documents of the other departments for compliance with GMP regulations (especially procedural and standard operating procedures);
  • Maintain the CAPA database, monitor the implementation of measures and regularly informs management of the compliance status;
  • Evaluation/processing of change control requests;
  • Implementation of new and amended regulations in operational practice related to the entire quality assurance system;
  • Training of employees on GMP topics in own and other areas of the company;
  • Collaboration in projects.

Job Requirements

  • Master’s degree in Pharmaceutical Science, Chemistry, Biology or related field
  • Sound professional experience in the pharmaceutical industry and quality assurance;
  • Professional experience in the field of pharmaceutical production and/or testing;
  • Solid experience in people management;
  • Digital literate
  • Qualified Person qualification is a plus;
  • Strong oral and written communication skills in English, good knowledge of Italian and German is a plus;
  • Independent working style, motivated and committed personality;
  • Very good communication skills and ability to work in a team;
  • Ability to work under pressure, flexibility and assertiveness;
  • High level of reliability and accuracy.
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