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Quality Assurance Associate

1 month ago

Stockholm, Sweden Karo Healthcare Full time

Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A. Since 2019, under EQT ownership, we're rapidly heading towards a €1 billion European leadership position in consumer health.

Join us at Karo Healthcare on our exciting journey. We're currently looking for a Quality Assurance Associate for our office in Stockholm.

Roles and responsibilities:

  • QAA admin support: Take charge of managing review comments and signatures in the electronic system at Karo.
  • Sample Management: Handle the management of QP and Complaints samples at our Stockholm office.
  • Audit oversight of Karo GMP, GDP and ISO audits: Develop detailed audit plans, schedule external audits, and confirm lead Auditors in the Karo Audit team.
  • Trainings: Facilitate training sessions in the Karo LMS system, including uploading training materials and assigning participants.
  • Complaints: Keep a close eye on non-Nordic, non-UK/IE, and non-DACH market complaints, registering and assigning them for root cause investigation.
  • Root cause investigation of medical device complaints: Prioritize medical device complaints for thorough investigation by escalating them to CMO.
  • Certification and license control: Conduct yearly checks of Certifications and licenses in the EU-database for GMP and GDP to ensure compliance.
  • FMD Alerts Management: Monitor our inbox daily for alerts and promptly investigate any issues according to the set procedure.
  • Quality inbox: Take control of handling Temperature excursions and other relevant quality assurance issues.
  • Release: Be responsible for releasing products to the market by signing the CoC based on the CoA for Medical Devices.
  • Out of stock reporting: Report any out of stock activities to all Karo direct countries.
  • Periodic review of QMS: Offer support and oversight in the periodic review of SOPs and processes in the Karo electronic system.
  • PQRs: Manage and request PQRs in the Karo electronic system.

Requirements

  • Master of science in Chemistry or biotechnology or Master of science in pharmacy
  • Fluent English and Swedish spoken and in writing
  • Structural mindset and strong in communication
  • Proved skills in building relationships
  • A can do attitude and solution oriented
  • Service minded and can easily identify gaps and activities needed to close gaps
  • Show strong evidence of our Karo values

Benefits

  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule and life work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a young, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values

 

  

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

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