QA Compliance Specialist

BSP Pharmaceuticals S.p.A.; Latina; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

An established industry player in pharmaceuticals is seeking a QA Compliance Specialist to ensure adherence to quality standards and manage deviations and complaints. In this role, you'll collaborate across departments to investigate issues, propose corrective actions, and support audits. With a strong focus on innovation and quality, this company offers a dynamic environment where your contributions will have a significant impact on the fight against cancer. If you have a Master's degree and relevant experience, this is an exciting opportunity to join a team committed to excellence in pharmaceutical manufacturing.

Competenze

• Master's degree in relevant fields is required.
• At least 2 years of experience in pharmaceutical organizations.

Mansioni

• Manage investigations related to deviations from production processes.
• Support audits and ensure compliance with quality standards.

Conoscenze

Investigation Management

Deviations Management

Complaint Management

Audit Support

GMP Knowledge

Sterility Assurance

English Proficiency

Formazione

Master's Degree in Chemistry

Master's Degree in Biology

Master's Degree in Pharmacy

Master's Degree in Chemistry and Pharmaceutical Technology

Descrizione del lavoro

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

BSP has been at the forefront in the fight agains 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 Organization (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

We are currently looking for a QA Compliance Specialist - that will mainly ensure:

Main activites:

Deviations and Investigations Management:

• Carry out investigations related to deviations from the production process with the aim of identifying their Root Cause through document verification and close cooperation with other departments in compliance with SOPs, current regulations and company quality standards;
• With the support of the other departments, propose corrective and preventive actions in order to ensure effective closure of deviations in compliance with quality standards and company procedures;

Complaint Management:

• Carry out investigations related to complaints from customers through understanding the causes and identifying the most appropriate corrective or preventive actions collaborating with other departments in order to maximize customer satisfaction, in compliance with SOPs, current regulations and specific agreements signed with customers;

Audit Support:

• Support the manager in the preparation and management of client and regulatory Audits.

BRR:

• Ensure compliance and completeness of the Batch Record, through collection and analysis of all necessary documentation;
• Documentary verification of material approval status, of check list and current SOPs, in compliance with applicable regulations (laws, GMP regulations, FDA, etc.) and company quality standards.

Main Requirements:

• Master's Degree in Chemistry, Chemistry and Pharmaceutical Technology, Biology, Pharmacy;
• Professional knowledge of English;
• At least 2 years of experience in the same role in pharmaceutical organizations;
• Good knowledge of Sterility Assurance;
• Good knowledge of GMP.

If you meet the requirements, apply now.

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 the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP