GMP Quality Assurance Specialist

Philogen S.p.A.; Belluno; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A biotech company in Belluno is seeking a GMP Quality Assurance Specialist. This role requires writing and reviewing essential documents, managing quality operations, and ensuring compliance with GMP regulations. The ideal candidate should have at least three years of Quality Assurance experience and excellent English proficiency. A competitive contract and salary will be provided based on experience.

Competenze

• Good scientific background (ideally in Biology, Biotechnology, etc.).
• Previous experience in Quality Assurance (at least three years).
• Comprehensive knowledge of GMP and regulations.

Mansioni

• Writing, reviewing and approving documents like SOPs and validations.
• Revision of production and quality control batch records.
• Managing GMP QA operations and change control.

Conoscenze

Scientific background

Experience in Quality Assurance

Knowledge of GMP regulations

High level of English

Attention to detail

Flexibility

Independence

Interpersonal skills

Formazione

Background in Biology or Biotechnology

Descrizione del lavoro

Overview

GMP Quality Assurance Specialist

Philogen S.p.A. is looking for a “ GMP Quality Assurance Specialist ” who will report to the GMP Quality Assurance Manager and who will contribute 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 offer :

A contract and salary proportional to the experience of the successful candidate.

Job location

Siena

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.