GMP Quality Assurance Specialist

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

Descrizione del lavoro

A biotechnology company is seeking a GMP Quality Assurance Specialist in Siena. The role involves managing quality policies, writing and reviewing critical documents, and ensuring compliance with GMP regulations. The ideal candidate will have at least three years of experience in Quality Assurance and a solid scientific background. A contract and salary will be proportional to experience. Interested candidates are encouraged to apply, and the company welcomes diverse applicants.

Competenze

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

Mansioni

• Write, review and approve quality documents.
• Revise production and quality control batch records.
• Manage GMP QA operations and documentation systems.

Conoscenze

Attention to detail

Interpersonal skills

Flexibility

Independent work

Formazione

Scientific background (Biology, 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.