05 ago
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7175-Janssen Cilag S.p.A. Legal Entity
|
Italia
05 ago
7175-Janssen Cilag S.p.A. Legal Entity
Italia
Quality Assurance Associate
Location: Latina, Italy. Contract: 12‑month fixed‑term. Company: Johnson & Johnson.
Job Description
Support quality assurance activities during new product introduction (NPI), technology transfer, and commercial launch, ensuring compliance with GMP and regulatory requirements from product introduction to commercial release. Maintain site compliance and contribute to product safety, efficacy, and quality.
Responsibilities
- Provide Quality support to NPI activities.
- Support the introduction of new products, technology transfer projects, and technical launches at the site.
- Ensure QA presence during shop‑floor activities related to NPI and technology transfers.
- Act as a quality reference in cross‑functional project teams (NPI, Technology Transfer, Validation, Technical Launch).
- Review project documentation to ensure adherence to cGMP and compliance timelines.
- Participate actively in meetings with site departments and global stakeholders, voicing quality issues.
- Identify and report project risks to the responsible manager promptly.
- Assist the manager in preparing for inspections related to new product introductions.
- Apply the In‑Process Assurance concept to support production activities.
- Manage deviation events in accordance with GMP, conducting investigations, impact assessment, and defining corrective and preventive actions (CAPA).
- Support definition, implementation, and closure of CAPAs, monitoring their effectiveness.
Qualifications
- Master’s degree or diploma in a scientific discipline, or equivalent education combined with experience in the pharmaceutical sector.
- 1–3 years of quality assurance experience, preferably in NPI or regulated environments.
- Knowledge of GMP and new product introduction processes.
- Experience managing production documentation, deviations, CAPA, and change control.
- Familiarity with quality information systems (e.g., SAP).
- Strong analytical skills, attention to detail, and problem‑so
📌 Quality Assurance Associate (Italia)
🏢 7175-Janssen Cilag S.p.A. Legal Entity
📍 Italia