GMP QUALITY ASSURANCE SPECIALIST

Experteer Italy; Siena; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Una società biotech in crescita cerca un 'GMP Quality Assurance Specialist' a Siena. Il candidato ideale avrà un forte background scientifico e almeno tre anni di esperienza in QA GMP. Le responsabilità includono la scrittura e l'approvazione di documenti, la gestione della qualità e l'interazione con team interfunzionali.

Competenze

• Esperienza precedente in assicurazione qualità (almeno tre anni).
• Conoscenza approfondita delle normative GMP.
• Ottimo livello di inglese, sia scritto che parlato.

Mansioni

• Scrivere, rivedere e approvare documenti (SOP, PQR, ecc.).
• Gestire le operazioni di QA GMP e le misure correttive.
• Interagire con altri membri dell'azienda.

Conoscenze

Attenzione ai dettagli

Lavoro in team

Flessibilità

Formazione

Diploma in Biologia o Biotecnologie

Descrizione del lavoro

Open positions
Job Title: GMP QUALITY ASSURANCE SPECIALIST
Location: Siena - Italy
Department: QA
Philogen S.p.A. is looking for a "GMP Quality Assurance Specialist" who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen's Quality System.
In particular the successful candidate will be responsible for:
* writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
* revision of production and quality control batch records;
* managing GMP QA operations, change control, deviation and documentation systems;
* identifying and recommending future improvements;
* implementing action plans;
* developing quality strategies and priorities and translating them into short and long-term objectives;
* risk assessment;
* interacting with other members of the company and clinical center staff.
The ideal candidate should have:
* A good scientific background (ideally in Biology, Biotechnology, etc.)
* Previous experience in Quality Assurance (at least three years);
* Comprehensive knowledge of GMP and other regulations with a good understanding of global quality standards relating to product development, submission and clinical experimentation;
* A high level of English language, both written and spoken;
* A high level of attention to detail and with the ability to prioritize working tasks;
* A strong flexibility in changing tasks and priorities;
* The ability to work independently as well as coordinate members of his/her team;
* Excellent interpersonal skills and ability to work in teams.
We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.
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