Material Quality Supervisor

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

Descrizione del lavoro

A leading pharmaceutical company in Latina is seeking a professional to supervise department activities and ensure compliance with regulations. The ideal candidate should possess an MA degree in CTF/Chemistry and have 5-6 years of experience in a similar role. Responsibilities include managing analytical specifications, overseeing secondary packaging, and supporting the manager in audits. This role requires knowledge of GMP and a proactive attitude, offering a chance to impact cancer treatments.

Competenze

• 5 / 6 years of experience in similar roles in complex organizations.

Mansioni

• Supervise department activities and support manager.
• Manage material master data management and analytical specifications.
• Oversee secondary packaging and customer/supplier relations.
• Support Manager in audits and quality agreements.

Conoscenze

GMP knowledge

Great can-do attitude

English working knowledge

Formazione

MA degree (CTF / Chemistry)

Descrizione del lavoro

About BSP Pharmaceuticals S.p. A

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

Responsibilities

• Supervise and monitor department activities, supporting the manager in charge
• Supervise and manage material master data management activities, issue analytical specifications and stability studies (through the LIMS system) in compliance with current procedures and national and international regulations.
• Supervision and management of activities related to secondary packaging: PCK change control, information on variable data related to presentations on authorized markets, artwork approval, Good To Print management, management of secondary packaging production recipes using dedicated software (SNI Vault & Printer).
• Supervision and management of customer relations for the approval of analytical specifications and artwork.
• Supervision and management of supplier relations for the management of activities related to material records.
• Management of analytical reduction programs for raw material specifications (excipients, reagents, and primary packaging).
• Verify compliance with the requirements for Under Test authorization for raw materials and Conditional Release for semi-finished products
• Support the Manager in drafting the Management Review
• Collaborate with the Manager, QP, and Quality Operation Manager in preparing and supporting, as SME (Subject Matter Expert), audits and inspections by external bodies, through the direction, coordination, and control of the subordinate structure and the management of GMP documentation under their responsibility
• Support the review of Quality Agreements with customers
• Support the Manager in preparing the budget for the area of competence

Qualifications

• MA degree (CTF / Chemistry..)
• 5 / 6 years of experience in similar roles in complex organizations
• Knowledge of GMP
• English working knowledge
• Great can-do attitude

If you meet the requirements, apply now.

Equal Employment Opportunity

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