CQ Specialist
Randstad AB / Organisationsutvecklarjobb / Helsingborg
2026-01-23
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CQ specialist - RP Sweden in Helsingborg
This position acts as the Responsible Person (RP) for Sweden under the Swedish Wholesale Dealer Authorisation, ensuring the license remains active for the commercialization of medicinal products. You will oversee the execution of Quality Management Systems (QMS) and Compliance at the Swedish marketing company, identifying opportunities for continuous improvement aligned with business objectives.
The role serves as a key point of contact for operational teams on Quality matters and liaises with multiple Quality organizations to ensure the timely resolution of issues while maintaining alignment with global quality visions and local regulations.
This is a consultant assignment with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant you get a competitive salary, benefits and collective agreements. Your consultant manager ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.
Deadline 2026-02-15 - the selection process and interviews will be ongoing, so please apply as soon as possible!
Responsibilities
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.
Qualifications
Qualifications
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.
Competencies
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.
Languages
Fluent English is required. Additional EMEA languages are considered a plus.
About the company
Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential.
With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world's most valued working life partner. By combining our passion for people with the power of today's technology, we support people and organizations in realizing their true potential. We call it Human Forward.
Ersättning Hourly
Så ansöker du Sista dag att ansöka är 2026-02-15
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Jobbnummer 9702234