Gmp Quality Assurance Specialist

Philogen S.P.A.; Rovigo; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading biotechnology company in Italy is searching for a GMP Quality Assurance Specialist. This role involves writing and approving quality documents, managing QA operations, and improving quality strategies. Candidates should have a degree in Biology or Biotechnology and a minimum of three years of experience in Quality Assurance. The position offers a contract and salary commensurate with experience.

Servizi

Competitive salary

Contract proportional to experience

Competenze

• Minimum three years of experience in Quality Assurance.
• Comprehensive knowledge of GMP regulations and global quality standards.
• High level of English proficiency, both written and spoken.

Mansioni

• Write, review and approve key quality documents.
• Manage GMP QA operations and documentation systems.
• Interact with other company members and clinical staff.

Conoscenze

Attention to detail

Flexibility

Interpersonal skills

Formazione

Degree 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 contribute to quality policies in support of Philogen’s Quality System.

In particular, the successful candidate will be responsible for:

Responsibilities

• writing, reviewing and approving documents (SOPs, PQRs, IMPDs, validations, research reports, etc.);
• revision of production and quality control batch records;
• managing GMP QAoperations, 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.

Qualifications

• 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 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.

Benefits

We offer :

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

Job location : Siena

Equal Opportunity

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.