Lab Oversight Specialist (Categoria Protetta) Lazio

Lab Oversight Specialist (Categoria Protetta)
Roma
Lazio, Lazio

Joining the QC Laboratory, within the Quality Unit of the manufacturing plant, you will guarantee the compliance of QC laboratory and the consistency of the associated reviewed data, laboratory notebooks, and completed Analytical Data Forms generated in the Quality Control (QC) lab including review and approval of lab exception reports (OOS and OOT) with the regulations in force (current EU GMP, US GMP), company quality standards and adherence to what is reported in the registration dossiers.

You will mainly focus on the activities below:

- Collaborates in the management of the company Quality System contributing to the achievement of the following Key Performance Indicators (KPIs):

- RFT & Deviation Rate

- Deviation, OOS CAPA Past due

- Quality & Regulatory Index

- Ontime closure

- Data integrity KPI

- Ensure that all process/equipment/systems are appropriately evaluated according to the Data Integrity principles, in details guarantee the execution of the Data Integrity Risk Assessment on the systems / processes, promptly communicating the gaps to the respective areas and ensuring the implementation of appropriate CAPAs in the established procedures and times.

- Guarantee periodic training to support the awareness and culture of the site on Data Integrity topic.

- Guarantee compliance with data integrity requirements on the management of paper and electronic data according to the data Life Cycle.

- Participate in customer visits and inspections of regulatory bodies (Self Audit / Audit);

- Participates in the preparation of periodic quality trends, intended for Management and Corporate disclosure;

- Organize staff reviews of all data notebooks and associated documents related to Analytical Data generated in the QC lab; ensure the accuracy of calculations, and that testing methods and Standard Operating Procedures (SOPs) have been followed during the performance of the analytical analysis; and verify the integrity and traceability of all data generated and reported;

- Coordinate the daily activities of Quality oversight team, monitoring the status, based on the priority defined by the Team leader.

- Ensure support as SME to QC to meet cGMP requirements and Corporate Standards

- Support the team for the topics of competence of quality oversight team performing training.

- Ensures fully adherence of GMP surveillance/oversight of QC activities in compliance with the procedures in force, providing the necessary support for such surveillance to be carried out, minimizing the risk of quality product impact

- Review reports drawn up by the personnel of QC oversight teams on the GMP surveillance performed, performing data analysis and identifying appropriate corrective / preventive actions

- Research, in collaboration with other plant structures, the optimization of processes in the field of quality continuous improvements and supports initiatives in the PPI field;

- Research, in collaboration with the other structures of the plant, the improvement of processes in the field of "quality continous improvements";

- Participate in customer visits and inspections of regulatory bodies (Self Audit / Audit);

- Ensure support to the Client about quality topics

- Drafting Risk Assessments and FMEAs for the assessment of risks associated with quality events related to the Quality Control department;

- Responsible for drafting Incident/Assessment, minor events related to analytical activities that do not fall within the category of deviation;

- Responsible for drafting Deviations/investigations regarding the quality control department

- Review and/or approval of the following documents (but not limited to):

- SOPs SST failures Laboratory investigations OOS Housekeeping/GMP surveillance report

**How will you get there?

**Studies/Diplomas/Training courses**:

- Scientific degree (Biology, Pharmacy, Chemistry, Biotechnology), or other

**Technical and computer skills**:

- cGMP (EU and US);

- MS Office

**Professional experience**:

- At least 1 years' experience in Quality departments in pharmaceutical companies (preferred)

**Languages**:

- Fluent English and Italian

**Personality

- Communication skills

- Negotiation skills

- Organizational skills

- Problem Solving

- Time Management