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Global PV (GPV) Quality Assurance Unit (QAU) Officer

BASED: Florence

CONTEXT
The candidate will join the GPV department within the QAU. The GPVQAU is in charge of the management and maintenance of the GPV Menarini Quality System.

MAIN ACTIVITIES AND RESPONSIBILITIES

The ideal candidate will be involved in several activities such as:
• Providing support to the GPVQAUM to manage the EU/EAA Pharmacovigilance System Master File for information under GPVQAU competence, reviewing PSMF information included in Annexes under Menarini affiliates competence.
• Writing and updating, as appropriate, the Global PV policies and procedures and cooperating with the GPVQAUM to ensure their implementation; acting as SOP-coordinator for the distribution of the corporate PV procedures to the concerned personnel; monitoring of Menarini affiliates procedures.
• Investigating and evaluating each deviation identified at Global PV level; supporting GPVQAUM in identifying any Corrective and Preventive Actions (CAPAs); monitoring the implementation of CAPAs up to the deviation closure; monitoring, if requested, the CAPAs efficacy; filing and archiving the related deviation form and CAPA documentation, including also the deviation log.
• Collaborating with the GPVQAUM to support the LDSUs and IDSCUs in the management of quality issues and activities, as appropriate.
• Supporting the GPVQAUM in identifying an appropriate audit strategy through the adoption of a risk-based approach, preparing in close collaboration with the GPVQAUM the strategic, tactical and operational audit planning; conducting or participating in specific audits, according to the relevant plan; collecting concerned information from affiliates; monitoring CAPA implementation.
• Supporting the GPVQAUM in defining Key Performance Indicators (KPIs); for KPIs under GPVQA competence, managing the measurements, evaluations and any KPI list update.
• Cooperating with GPVQAUM in providing responses to Licensors/Partner’s requests regarding quality issues.
• Being involved in the validation activities regarding computerised systems.
• Cooperating with GPVQAUM in preparing inspections performed by Competent Authorities as well as audits performed by Licensors/Partner’s auditors and to ensure appropriate follow-up as necessary
Interactions with several internal stakeholders both at Global level (Regulatory Affairs, Medical Marketing, Scientific Service, PV) and Affiliate level (PV), as well as external consultants.

JOB REQUIREMENTS

• Education (mandatory): Master degree in Life Sciences (Pharmacy, Biology, ...)
• Years of experience (2-3 officer); Universitary Master in PharmacoVigilance and/or previous experience (1-3 years) in PharmacoVigilance and/or Quality Assurance (GVP, GMP, GCP, etc.) is preferred
• Qualification and skills: precision, timeliness, good organisation skills, teamwork, confidence with electronic tools (MSOffice)
• Language skills and level of proficiency: English intermediate (minimum, as all work documentation and most of the communication shall be executed in English)

 

Degrees of interest: Master degree in Life Sciences (Pharmacy, Biology, ...)