· Categoria professionale
Scientifico / Farmaceutico - Quality Assurance Specialist
INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
· Data inizio
· Riferimento esterno
The research is aimed in particular at people protected by Law no. 68 of 12 March 1999: Targeted placement of people with disabilities.
For a leading company in the pharmaceutical field, we'are looking for a Quality Assurance and Audit specialist.
The candidate will provide support in those tasks related to GMP compliance audits to be performed mainly in Europe and he/she‘ll provide support to the Qualified Person in carrying out the QA matters in GMP rules.
• Carry out and evaluate audits of plasma and associated service providers (laboratories, warehouse, transport and central offices), following up on corrective and preventive actions derived from the observations found. Audits to be performed mainly in Italy and Europe.
• Maintain updated the Technical Information of the suppliers through the process of Continuous Qualification, to assure the quality and security of the plasma according to the legislation in force and the specifications marked by the company, giving support to the Head of Department of Certification of Suppliers.
• Coordinate quality technical and operational aspects for the correct management of plasma related activities.
• Review and analyze regulatory information on audits performed and inspections received from the Competent Authorities.
• Maintain the Internal Audit program and follow-up of the audits, including GDP and GMP scope
• Implementation of the GMP rules, to be in compliance with the role of Head of Quality Assurance, as described in the EU Guidelines of GMP, Chapter 2.
• Management of calibration, qualification and re-qualification (IQ/OQ/PQ) of instrumentation destined to deal with plasma (refrigerators, trucks, temperature monitoring).
• Participate actively in performing internal audits as auditor, concerning GDP, GMP, ISO 9001, Farmindustria Certification rules.
• Scientific degree in pharmaceutical or biomedical area.
• At least three years of experience in a similar position, preferably in a pharmaceutical and multinational context, in environments of Good Practice Auditing (GxPs) and Good distribution Practices (GDP's).
• Mother tongue knowledge of Italian; fluent English; the knowledge of Spanish is considered a plus.
• Knowledge of Microsoft Office
• Availability to travel up to 40% of the time
• Soft skills: result orientation, working autonomy, stress tolerance, planning and organization, problem solving,
Disponibilità oraria: Full Time