Clinical QA Audits Specialist

Grifols, S.A; Sant Cugat del Vallès; Ibrido; EUR 60.000 - 80.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid model

Flexible schedule

Descrizione del lavoro

Grifols, S.A. seeks an experienced QA Auditor to plan and conduct audits of CROs, vendors, and investigator sites, ensuring compliance with applicable regulations and standards.

The role also conducts internal GCP process audits and reviews procedures for clinical audits, providing guidance to clinical staff on resolving findings. The candidate should have a PhD or Master in pharmaceuticals or life sciences, 2–3 years of GCP/GCLP QA experience, advanced English, and travel availability.

Competenze

• PhD or Master in pharmaceuticals or life sciences related field.
• 2–3 years of practical experience in GCP and GCLP quality assurance or compliance.
• Advanced English language required.

Mansioni

• Plan and conduct audits of CROs, vendors, investigator sites; assess compliance with regulations and standards.
• Conduct internal audits of Clinical GCP processes for SOPs, company policy, and regulations/standards.
• Review internal procedures related to planning, conduct and oversight of clinical audits.

Conoscenze

GCP/GCLP experience

Quality assurance

Travel availability

Advanced English

Formazione

PhD or Master in pharmaceuticals or life sciences

Descrizione del lavoro

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.

What your responsibilities will be

• Plan and conduct audits of CROs, vendors, investigator site audits. Assess compliance with applicable regulations and standards.
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards.
• Contribute to the review of the internal procedures related to the planning, conduct and oversight of clinical audits.
• Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings.
• Provide guidance to Clinical staff in resolving audit findings in a compliant manner.
• Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• You have a Ph.D. Master, Bachelors in pharmaceuticals or life sciences related field.
• You have at least 2-3 years of practical experience in GCP and GCLP quality assurance or compliance.
• Your English is advanced.
• You have availability to travel.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available at www.grifols.com.

We believe in diverse talent and want to remove any barriers that may hinder your participation.

Grifols is an equal opportunity employer.

Flexibility for U Program: Hybrid Model

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h. (with the same flexible start time).

Benefits package

Contract of Employment: Permanent position