QA Manager & Qualified Person – GMP Quality Leader

R&D Partners; Malmö kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

R&D Partners in Sweden is seeking an experienced QA Manager / Qualified Person (QP) to oversee quality assurance for sterile pharmaceutical products. You will ensure GMP compliance, review batch documentation, and lead investigations and CAPAs within a cross-functional environment.

The role requires eligibility to act as a QP under European legislation, a pharmacy/biomedical degree, and at least five years of GMP pharmaceutical experience.

Qualifications

• Five years’ experience in a GMP-regulated pharmaceutical manufacturing environment.
• Eligible to perform Qualified Person responsibilities under European legislation.
• Experience with deviations, OOS investigations, CAPA and change controls.
• Experience supporting regulatory inspections and audits.
• Sterile/aseptic manufacturing experience is desirable.

Responsibilities

• Review batch documentation and make disposition decisions.
• Investigate quality deviations and assess impact on product quality and compliance.
• Lead OOS investigations and assess associated risks.
• Authorize quality documentation in line with batch disposition outcomes.
• Initiate and approve SOPs, CAPAs, and change controls.
• Participate in regulatory inspections, audits, and internal assessments.
• Provide independent QA oversight to manufacturing activities for GMP compliance.
• Support product complaint investigations and cross-functional projects.
• Provide GMP guidance to manufacturing and other functions.
• Contribute to ongoing quality system improvements.

Skills

Communication skills

English fluency

Project coordination

Stakeholder management

Analytical thinking

Education

Degree in Pharmacy/Pharmaceutical Sciences/Chemistry/Life Sciences

Job description

R&D Partners in Sweden is seeking an experienced QA Manager / Qualified Person (QP) to oversee quality assurance for sterile pharmaceutical products. You will ensure GMP compliance, review batch documentation, and lead investigations and CAPAs within a cross-functional environment.

The role requires eligibility to act as a QP under European legislation, a pharmacy/biomedical degree, and at least five years of GMP pharmaceutical experience.