QAC Specialist

BSP Pharmaceuticals S.p.A.; Latina; On-site; EUR 35,000 - 40,000; Full time

Job summary

BSP Pharmaceuticals S.p.A invites a skilled QA professional to join our CDMO operations in Italy. You will review batch records, support investigations, and help keep GMP documentation up to date across QA and manufacturing areas.

The role emphasizes compliance, change control, and safety, requiring a strong attention to detail and the ability to draft clear reports in English. Competitive salary and career growth offered in a multinational setting.

Qualifications

• MA degree in Chemistry or related field.
• English working knowledge.
• Great can-do attitude.

Responsibilities

• Batch Record Review: ensure compliance and completeness of batch records and SOPs.
• Investigation Management: assist in deviations and complaints investigations and CAPA reports.
• Procedures: keep SOPs up to date and draft required documentation per GMP.
• Change Management: assist in change assessments and reports.
• Safety: adhere to EHS obligations per applicable regulations.

Skills

English proficiency

Can-do attitude

Education

MA degree in Chemistry or related field

Job description

BSP Pharmaceuticals S.p.A is a Contract Development and Manufacturing Organization (CDMO). The BSP campus hosts 2 segregated facilities to serve the clients with development from pre-clinical GLP to cGMP manufacturing for clinical and commercial supply of Cytotoxic and High Potent Oncology drugs and Non-Cytotoxic, innovative compounds for Immunotherapy and other therapeutics applications. Facilities designed to handle small and large molecules as ADCs (conjugation and fill finish), Peptides, Proteins, Oligonucleotides and Nano Medicines. BSP is technologically developed to meet the needs of innovators, with its High Containment Facility designed to offer a full range of integrated services aimed to support the entire life cycle of a product, from the formulation and process development/optimization, through scale up/scale down studies.

Come for Science. Stay for Purpose.

Posizione

• Batch Record Review: Ensure the compliance and completeness of batch records by collecting and analyzing all necessary documentation. This includes verifying the approval status of materials, checklists, and current Standard Operating Procedures (SOPs), in adherence to applicable regulations (laws, GMP standards, FDA requirements, etc.) and company quality standards.
• Investigation Management: Support the supervisor in managing investigations into deviations and complaints, and in preparing comprehensive reports that include corrective and preventive actions (CAPA), in accordance with company procedures.
• Procedures: Ensure that SOPs and operational procedures within the area of responsibility are kept up to date by drafting the necessary documentation as required, in compliance with current GMP requirements.
• Change Management: Support the supervisor in managing changes by drafting assessment reports in line with company requirements and procedures.
• Safety: Regarding EHS (Environment, Health, and Safety) obligations and responsibilities, please refer to the provisions of Article 20 of Legislative Decree 81/08 (as amended) – Obligations of Workers.

Requisiti

• MA degree (CTF/Chemistry, etc...)
• English working knowledge
• Great can-do attitude

Altre informazioni

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is : 35-40k

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.

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