GMP Quality Assurance Specialist

Philogen S.p.A.; Siena; In loco; EUR 40.000 - 60.000; Tempo pieno

Vantaggi offerti da questo lavoro

Dynamic working environment

Competitive salary based on experience

Descrizione del lavoro

A biotech company leader in anti-tumor therapies is seeking a GMP Quality Assurance Specialist in Siena. The role involves writing and approving documents, managing GMP QA operations, and developing quality strategies. Ideal candidates have a strong scientific background, excellent fluency in English, and at least three years of experience in Quality Assurance. The company offers a dynamic work environment with a contract and salary proportional to experience.

Competenze

• 3+ years of experience in Quality Assurance.
• Understanding of GMP and global quality standards.
• Flexibility in prioritizing tasks.

Mansioni

• Write and approve quality documentation.
• Manage GMP QA operations and documentation.
• Identify improvements and implement action plans.

Conoscenze

Scientific background

GMP knowledge

Attention to detail

Interpersonal skills

Ability to work independently

Fluency in English

Descrizione del lavoro

Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified "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;
• 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 dynamic and stimulating working environment;
• 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.