cq specialist.

Responsible Person (RP) & GDP Duties

• License Maintenance: Act as the designated RP for the Swedish wholesaler license, focusing on authorized activities and record accuracy.
• Product Oversight: Responsible for storage and distribution oversight according to international and local regulations.
• Supply Chain: Approve subcontracted activities impacting GDP and ensure all suppliers and customers are qualified.
• Operations: Coordinate and perform recall operations, handle relevant complaints efficiently, and decide on the final disposition of returned, rejected, or recalled products.
• Training: Implement and maintain continuous GDP training programs for all appropriate roles.

Quality Management & Processes

• QMS Implementation: Maintain and implement the local Quality System and ensure compliant procedures meet business needs.
• Repack/Relabel: Define and implement quality requirements for repackaging and relabelling operations according to product owner specifications.
• Issue Management: Support the escalation and resolution of quality issues and notify Health Authorities regarding product shortages.
• Documentation: Manage all local procedures, work instructions, and associated documentation, providing input to regional or global drafts where required.

Compliance & Audits

• Inspections: Support the successful management of Health Authority inspections, external agency audits, and internal quality audits.
• Risk Mitigation: Proactively identify and mitigate compliance risks through internal audits and self-inspections.
• Management Review: Act as the Quality representative for Management Reviews and evaluate process capabilities against industry standards.
• Change Control: Ensure a robust change control system is implemented for all activities under Quality responsibility.

• Eligibility: Ability to meet the legal requirements to act as a GDP Responsible Person in Sweden.
• Education: Undergraduate degree in Life Sciences, Engineering, Scientific, or Business disciplines.
• Experience: Proven track record in Continuous Improvement and Quality Systems.
• Regulatory Expertise: Experience interfacing with regulatory agencies and resolving complex compliance issues.
• Technical Skills: Proficiency in KPI frameworks, QSMR, Change Control, Audits, and CAPA. Strong technical writing and data storytelling skills.

• Strategic Focus: Strategic Quality Management with a focus on business outcomes.
• Analytical Skills: Strong prioritization and structured problem-solving abilities.
• Communication: Effective communication and change management skills within complex or virtual environments.

• Fluent English is required. Additional EMEA languages are considered a plus.