Qa Process Specialist

01 ago - Italia
Johnson & Johnson Innovative Medicine

Position QA Process Specialist – Borgo San Michele, Latina, ItalyResponsibilities
- Manage complex investigations ensuring compliance with GMP, regulatory, and company requirements.
- Act as Quality Leader in the approval of investigations and contribute to the definition of investigation strategies.
- Act as Escalation Lead, facilitating the escalation process in accordance with company procedures.
- Serve as a tutor for new hires in investigation training, supporting them through proper planning until full autonomy is achieved;
coordinate the team during support activities to operational departments on the shop floor.
- Act as backup in the Quality Oversight process for Production and Quality Control departments, contributing to strengthening the site’s compliance status: execution of controls defined in the annual plan, coordination of periodic meetings with management to evaluate results, trends, and improvement opportunities.
- Ensure a constant presence in operational areas,



providing support in training personnel on new regulations and ensuring that all procedures and work instructions are aligned with the applicable quality system.
- Act as Quality point of reference for projects related to LCM products, serving as the first point of contact for the technical department and interfacing with all involved global functions.
- May act as backup in the management of NPI projects.

Qualifications
- Master’s degree or diploma in a scientific field, or an equivalent combination of education and experience in the pharmaceutical industry.
- At least 2 years of experience in quality field in a pharmaceutical company, and experience as an investigator.
- Excellent English language skills.
- Good knowledge of Microsoft Office suite.

Salary €33,700.00 – €54,395.00 per year
Benefits Annual premio, vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, financial, physical and mental health programs, s

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