IRBM Group has a GMP-certified Contract Manufacturing Organization, ADVENT, located in Pomezia (Rome) within the IRBM campus and dedicated to production of clinical lots of recombinant adenovirus to support Phase I and Phase II clinical trials for vaccine and gene therapy applications. Our GMP is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the regulatory guidelines of both FDA and EMA. Over the years, the GMP team has built an outstanding track record in the successful production of clinical lots and is committed to the highest GMP quality standard.
IRBM also provides several integrated pre-clinical laboratory services across the entire drug discovery process, ranging from target validation to clinical candidate molecule selection, including a GCLP/GLP testing facility.
We have an opening for a talented and highly motivated Junior QA Specialist for joining the IRBM/Advent QA team. The primary responsibilities will be to ensure GMP quality and compliance of ADVENT with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices) as well as support the non-clinical work at IRBM on ensuring GLP studies are conducted in a compliant manner. The successful candidate will be able to work under pressure and meet deadlines. A collaborative attitude and ability to multitask are essential for this position.
- Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and expectations and established agency requirements/guidelines
- Review of the data produced in the phases of the pharmaceutical production process (Batch Record Review) in order to verify the compliance of the product with the regulatory requirements;
- Conduct QA review of GCP protocols, ICFs, CSRs and other clinical trial specific documents.
- Conduct QA review of GLP reports.
- Identification of opportunities to improve current compliance with GMP requirements in the various plant processes;
- Interaction and collaboration with the various company departments to support the definition of the data review process.
- Support in generating KPI and trend analysis as required
- Ensure rapid communication of QA issues, including deviation or non-compliance, to appropriate leaders and colleagues.
- Support for Non-compliance and CAPA related activities
- Contribute to registry management
- Schedules and/or delivers yearly GMP and GLP training for internal staff.
- Good communication skills, both verbal and written. Working knowledge of spoken and written English.
- Outstanding organizational, record-keeping, and problem-solving skills.
- Ability to work well independently and/or in a team to meet tight timelines.
- Knowledge of GXP principles.
- Minimum of 1 year in the Pharmaceutical industry as QA
- Understanding of GMP, GDP, GLP and ICH clinical requirements