Qualified Person

Fastnet - The Talent Group; São Paulo; Híbrido; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading biopharma company in São Paulo is seeking an experienced Qualified Person (QP) to ensure compliance in the release of drug products. The role offers a dynamic and collaborative environment, emphasizing quality assurance within a hybrid work model. Candidates should have QP status with 3-5 years of experience and strong knowledge of EU/FDA regulations.

Serviços

Collaborative working environment

Flexibility in work location

Opportunity to contribute to healthcare advancements

Qualificações

• Minimum of 3-5 years as named QP under an MIA/IMP MIA.
• 5+ years in Quality Assurance within an EU-licensed pharma/biopharma facility.
• Proven track record in regulatory inspection readiness.

Responsabilidades

• Take full responsibility as QP for batch certification.
• Ensure product release meets GMP requirements.
• Provide technical QA leadership.

Conhecimentos

QP status

Experience in Quality Assurance

Hands-on experience in aseptic/sterile manufacturing

Knowledge of EU/FDA GMP regulations

Effective communication skills

Descrição da oferta de emprego

Ready to make an impact in a dynamic, fast-paced biopharma environment?

We're looking for an experienced Qualified Person (QP) to join a high-performing quality team based in Cork. This hybrid contract role (12 months) offers the opportunity to contribute to the safe and compliant release of both commercial and clinical drug products-with a focus on sterile manufacturing and biologics.

Key Responsibilities

• Take full responsibility as QP for batch certification in line with EU Directives (2001/83/EC, 2001/20/EC) and Annex 16/13 as applicable.
• Ensure product release meets GMP requirements and complies with Marketing Authorisation (MA) or Clinical Trial Authorisation (CTA) standards.
• Provide technical QA leadership, ensuring robust compliance across manufacturing and supply processes.
• Support internal audits and regulatory inspections (HPRA, FDA, etc.), and represent Quality in cross-functional teams.
• Participate in management reviews, continuous improvement initiatives, and oversee Product Quality Reviews (PQRs).
• Monitor and promote adherence to site licenses and GxP regulations.

Qualifications & Experience

• QP status with a minimum of 3–5 years experience acting as a named QP under an MIA/IMP MIA.
• 5+ years in Quality Assurance within an EU-licensed pharma/biopharma facility.
• Hands-on experience in aseptic/sterile manufacturing, biologics, or clinical trial materials is highly desirable.
• Proven track record in regulatory inspection readiness, technical writing, and quality system oversight.
• Strong knowledge of EU/FDA GMP regulations and global quality standards.
• Effective communication, mentoring, and decision-making skills.
• Ability to analyze risk and drive effective, compliant solutions.

Why Join?

• Be part of a company that’s passionate about advancing healthcare through innovation.
• Gain experience across clinical and commercial operations in a supportive, collaborative setting.
• Work in a hybrid capacity, balancing on-site influence with flexibility.