Karo Healthcare

Product Quality Manager

Karo Healthcare

full-time

Posted on:

Location Type: Hybrid

Location: Stockholm • Sweden

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About the role

  • **What you’ll be doing**
  • - Act as a key Quality representative for Contract Manufacturing Organisations (CMOs), ensuring compliance with GMP, GDP and Directive 2001/83/EC
  • - Evaluate, qualify, approve and manage suppliers within Karo’s Global Quality Management System
  • - Lead and participate in Technology Transfer and validation activities from a QA perspective
  • - Drive Product Quality Review (PQR), deviation, change control and CAPA processes in line with global QMS
  • - Take ownership of selected Global QA processes and contribute to a project-driven way of working within the function
  • - Plan, lead and conduct external audits of CMOs as well as internal audits; approve audit reports and follow up actions
  • - Ensure product compliance both before and after release, including deviation handling and follow-up
  • - Review and approve GMP documentation from CMOs (e.g. specifications, validation protocols/reports, stability documentation, manufacturing instructions)
  • - Issue and/or approve regulatory documentation (Module 3) and co-sign QA agreements where applicable
  • - Build strong, collaborative relationships with suppliers and internal stakeholders across Quality and Operations

Requirements

  • **Requirements**
  • - University degree in a scientific or technical field; Master’s degree in Pharmacy, Medicine, Chemistry or Chemical Engineering is preferred
  • - At least 2 years of experience within Quality Assurance in the pharmaceutical and/or medical device industry
  • - Solid knowledge of GMP, GDP and EU pharmaceutical regulations (including Directive 2001/83/EC)
  • - Experience working with CMOs and outsourced manufacturing environments
  • - Comfortable in a fast-paced, hands-on setting with multiple stakeholders and priorities
  • - Structured, detail-oriented and confident in decision-making within a regulated environment
  • - Fluent in English; additional languages are a plus
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssuranceGMPGDPDirective 2001/83/ECTechnology TransferValidationCAPARegulatory DocumentationAudit ManagementDeviation Handling
Soft Skills
CollaborationDecision-makingDetail-orientedStructuredInterpersonal SkillsLeadershipOrganizational SkillsCommunicationAdaptabilityProblem-solving
Certifications
Master’s degree in PharmacyMaster’s degree in MedicineMaster’s degree in ChemistryMaster’s degree in Chemical Engineering