Development and Validation Specialist

Job title:

Development and Validation Specialist

Company:

Bial

Job description

Join Our Mission to Improve Lives WorldwideThis role involves performing analytical and documentation activities essential for the development and validation of analytical methods, cleaning procedures, and manufacturing processes. The focus will be on drug substances and finished drug products at various stages of their lifecycle, including new chemical entities, clinical trial materials, and commercial products.The Impact You’ll Make

• Perform physical and chemical tests under the scope of Development and Validation activities;
• Support manufacturing activities of Clinical Trial Materials and Commercial Products;
• Prepare technical documentation to support Regulatory and Validation activities;
• Actively contribute to the Quality Management System (change controls, deviation, OOS/T/E, complaints);
• Adhere to and enhance compliance with GMP, regulatory, and legal requirements;
• Contribute to equipment and infrastructure qualification.

What You’ll Bring

• Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or equivalent;
• 5 years of experience in similar roles in the Pharmaceutical Industry (preferably);
• cGMP and analytical instrumental analysis relevant experience;
• Updated knowledge and experience of technical guidelines, regulatory and legal requirements under the scope of pharmaceutical development and validation activities;
• Team player;
• Curious, dedicated and enthusiastic;
• Strong computer and digital skills;
• Fluency in written and spoken English.

Create Your Path@BIAL“Working in marketing enables me to act as a link between the sales and medical departments, all with the common goal of creating impactful projects in the business we operate in..”Francesca Lazzara (Manager, Regional Sales – Italy)JOIN US!To know more about BIAL, visit us on . Follow us on and

Expected salary

Location

Italia

Job date

Sun, 23 Feb 2025 07:51:19 GMT

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