Quality Assurance Associate

at  Karo Healthcare

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.

REQUIREMENTS

• Master of science in Chemistry or biotechnology or Master of science in pharmacy
• Fluent English 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

• QAA admin support : initiate review, administrate review comments internally and externally, follow up on review period for updating, administrate signatures and archiving in electronic system at Karo
• Sample Management (QP samples and Complaints samples) in the Stockholm office
• Audit oversight of Karo GMP, GDP and ISO audits: Create yearly audit plans, schedule external audits with Karo suppliers, create agendas and confirm lead Auditors in Karo Audit team
• Trainings: Administrate training sessions in Karo LMS system. Including uploading training materials and assigning training participants, with input from responsible QA member. Monthly follow up on statistics for QA onboarding in LMS as input to commercial Quality team meetings
• Complaints: monitor complaints inboxes on a daily basis and register complaints for non-Nordic,non-UK/IE markets and non-DACH markets. Assign complaint to PQM for root cause investigation by CMO
• Root cause investigation complaints for medical device: Escalate medical device complaints to CMO
• Certification and license control: yearly control of Certifications and licenses in the EU-database for GMP and GDP
• FMD Alerts Management: Monitor inbox for alerts on a daily basis, investigate Alerts according to procedure
• Quality inbox: Handling of Temperature excursions and other relevant QA issues
• Release: Release product to market by signing of CoC based on CoA for Medical Devices
• Out of stock reporting: report to all Karo direct countries out of stock activities
• Periodic review QMS: support and keep oversight of periodic review of SOPs Processes in Karo electronic system
• PQRs: Request late PQRs, keep oversight, request Regulatory data, upload and administrate PQR in Karo electronic system