QA Validation Specialist

JR Italy; Latina; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical industry is seeking a QA Validation Specialist to join their Quality Assurance Validation Team. The role involves analyzing technical documentation, drafting validation protocols, and ensuring compliance with company protocols. Candidates should have a MA degree and relevant experience in a complex organization.

Competenze

• 1-2 years of experience in similar roles within complex organizations.
• English working knowledge.

Mansioni

• Ensure analysis and evaluation of technical documentation related to manufacturing processes.
• Draft Validation Protocols by researching data from other business functions.
• Ensure correct validation of processes and preparation of Validation Reports.
• Analyze validation activities through data collection and analysis.

Conoscenze

Knowledge of GMP

Data Analysis

Technical Documentation Analysis

Formazione

MA degree (e.g., Chemistry, Chemical Engineering)

Descrizione del lavoro

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BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight against cancer since 2006.

Innovation is the hallmark of BSP, with investments in new technologies and production methods in a high containment plant.

We are one of the most important Contract Development and Manufacturing Organizations (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

We are currently looking for a QA Validation Specialist for our Quality Assurance Validation Team.

Main Activities:

1. Analysis of technical documentation: Ensure the analysis and evaluation of technical documentation related to manufacturing processes or cleaning and sanitization procedures that have to be submitted for validation.
2. Defining Protocols: Drafting the Validation Protocols by researching and acquiring data and information from other business functions.
3. Validation: Ensure the correct validation of the processes, cleaning in compliance with company protocols and procedures through the execution of operational activities. Preparation of Validation Reports.
4. Data Analysis: Ensure correct analysis of validation activities through data collection and analysis, in compliance with company protocols and procedures.

Main Requirements:

• MA degree (e.g., Chemistry, Chemical Engineering, etc.);
• 1-2 years of experience in similar roles within complex organizations;
• Knowledge of GMP;
• English working knowledge.

At BSP, we believe in an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. We respect diversity, different backgrounds, and experiences, providing equal opportunity for all.