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Junior QA Specialist at ADVENT – Ref. 169 A

Position: Junior QA Specialist at ADVENT – Ref. 169 A

ADVENT is a GMP-certified Contract Manufacturing Organization, located in Pomezia (Rome) within the IRBM campus and dedicated to production of clinical lots of recombinant adenoviruses to support clinical trials for vaccine and gene therapy applications. ADVENT is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) as well as to perform QC tests of commercial vaccines and is compliant with the regulatory guidelines of both FDA and EMA. Over the years, ADVENT has built an outstanding track record in the successful production of clinical lots and is committed to the highest GMP quality standard. A key partnership is with AstraZeneca for the manufacture of clinical trial supplies and release testing of commercial COVID-19 vaccine, now authorized by the MHRA and EMA.

Job Description

We have an opening for a talented and highly motivated Junior QA Specialist for joining the 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). 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.

Key Responsibilities:

  • Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP), expectations and established agency requirements/guidelines.
  • Contribute to registry and archive management and to all documents issuing and distribution.
  • Contribute to schedule, deliver and record GMP training for internal staff.
  • Support to schedule and record the internal inspection and relevant CAPA.
  • Support to the preparation and management of the documents for customers/regulatory audits.
  • Support to the activities of supplier qualification and approval and relevant documentation management.
  • Review of the data produced in the phases of the pharmaceutical production process (Batch Record Review) to verify the compliance of the product with the regulatory requirements.
  • Review of the data produced during analytical tests execution to verify the compliance of the results to the acceptance criteria.
  • Support in managing deviations or non-compliance.
  • Support for Non-compliance and CAPA related activities implementation.
  • 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.
  • Identify opportunities to improve current compliance with GMP requirements in the various plant processes.

Leadership competencies/skills:

  • 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.

Requirements:

  • Minimum of one year in the Pharmaceutical industry as QA
  • Understanding of GMP and ICH clinical requirements
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