GxP Compliance & QA Consultant — Remote/Hybrid

ProPharma; Stockholms kommun; Híbrido; SEK 120.000 - 180.000; Jornada completa

Descripción de la vacante

ProPharma is seeking a Compliance and Quality Assurance Consultant to support QA and regulatory/GxP projects. The role includes QMS development, audits, and CAPA implementation across client sites, with travel as needed.

The ideal candidate holds a science degree with 5–8 years in QA/GxP and strong knowledge of CFRs, EU GMP, and ICH guidance. Fluency in English and Swedish is required; SWE eligibility preferred.

Formación

• Bachelor’s degree in a scientific discipline or equivalent.
• MSc/PhD in a scientific field preferred.
• 5–8 years QA and regulatory/GxP experience.
• Qualified Person registration preferred but not essential; eligible in Sweden preferred.
• Fluent in English and Swedish; strong regulatory knowledge (US FDA, ICH, EMA, MHRA).

Responsabilidades

• Represent the company in quality assurance and regulatory/GxP matters.
• Consult on projects and support management of CQA initiatives.
• Oversee QA activities on MIA/WDA projects and LTS operations.
• Develop and improve QMS, SOPs, and CAPA processes.
• Travel as required and contribute to client communications.

Conocimientos

Quality Assurance

Regulatory/GxP

QA auditing

QMS development

CAPA implementation

Risk-based project management

English and Swedish

Travel readiness

Educación

Bachelor’s degree in a scientific discipline

MSc/PhD preferred

5–8 years QA/GxP experience

Qualified Person registration preferred (not essential)

Herramientas

CFRs & EU GMP/GDP knowledge

Descripción del empleo

ProPharma is seeking a Compliance and Quality Assurance Consultant to support QA and regulatory/GxP projects. The role includes QMS development, audits, and CAPA implementation across client sites, with travel as needed.

The ideal candidate holds a science degree with 5–8 years in QA/GxP and strong knowledge of CFRs, EU GMP, and ICH guidance. Fluency in English and Swedish is required; SWE eligibility preferred.