Beca De Automatización Y Control

Acciona S.A; Madrid; On-site; EUR 80,000 - 110,000; Full time

Job summary

IQVIA is hiring for a Plan and conduct independent clinical (GCP) audits across Europe to assess compliance with regulations. The role involves preparing reports and advising on interpretation of regulations and corporate policies.

Requires 5 years QA audit experience, travel 30-50%, and a certification to audit in Italy. You will support QA initiatives and may supervise trainings for staff.

Qualifications

• Certified to conduct audits in Italy per 2011 decree.
• 5 years in pharmaceutical/QA audits with 3 years in audits.
• Experience in clinical trial investigator site audits.
• Strong knowledge of QA processes and regulatory environments.

Responsibilities

• Plan, schedule, conduct, report and close audits across involved countries.
• Evaluate audit findings and distribute reports to stakeholders.
• Provide interpretation of regulations and guidelines to project teams.
• Develop corrective action plans and monitor their closure.
• Review investigations, RCA, CAPA, and EC plans for QA events.
• Lead QA initiatives and mentor staff.
• May perform pre-inspection visits and host audits.

Skills

QA Audits

Clinical Audits

Regulatory Knowledge

Interpersonal Skills

Training

Project Mgmt

Documentation

Education

Audit Certification Italy

Tools

Word

Excel

Databases

Job description

Madrid, Spain
Lisbon, Portugal
Budapest, Hungary
Belgrade, Serbia
Tallinn, Estonia
Zagreb, Croatia
Riga, Latvia
Prague, Czech Republic
Sofia, Bulgaria
Ljubljana - Dunajska, Slovenia
Bucuresti, Romania
Full time
R
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of
regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
- Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
- Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
- Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
- Lead/collaborate/support in QA initiatives/projects for quality, process improvements
- Assist in training of new Quality Assurance staff
- May be required to manage Quality Issues
- May present educational programs and provide guidance to operational staff on compliance procedures
- May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.
Qualifications
- The right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
- Travel 30-50% mainly in Europe.
- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
- Experienced in the conduct of clinical trial Investigator site audits.
- Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Strong training capabilities.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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