QAC Specialist
AziendaBSP Pharmaceuticals Sede Latina, Italia Professione/ Funzione Qualità Tipo di sede di lavoro In presenza Retribuzione Intervallo 35.000,00-40.000,00 EUR all'anno
Descrizione azienda
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
Activities:
- 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
Main Requirements:
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.
We are BSP
Descrizione azienda
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
Activities:
- 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
Main Requirements:
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.
We are BSP