Quality Assurance Manager

Medison Pharma

. Participate in designing, implementing, maintaining, and improving the quality system .

Posted 10/19/2026contractCroatiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) with a strong focus on regulatory compliance, including GMP and GDP standards. Proficient in developing and reviewing SOPs, conducting audits, and implementing continuous improvements in quality processes.

Highest-signal resume keywords

Quality Management Systems (QMS)Good Manufacturing Practice (GMP)Good Distribution Practice (GDP)Quality AuditingRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SOP CreationRoot Cause AnalysisQuality DocumentationRegulatory InspectionsCAPA ManagementVendor ManagementRisk-Based PrinciplesSelf-InspectionQuality Assurance (QA)Quality Control

Soft Skills

Excellent Communication SkillsCritical ThinkingProblem SolvingOrganizational AbilitiesCollaboration

Industry Keywords

Healthcare SectorQuality AssurancePharmaceutical RegulationsGxPVendor Oversight

About the role

Key responsibilities & impact

Participate in designing, implementing, maintaining, and improving the quality system
Independently initiate and review SOP updates and create new SOPs
Oversee review of SOPs and associated documentation to ensure periodic review requirements are met
Provide hands-on quality expertise to colleagues and partners to support their quality and business needs
Participate in GxP vendor management program, vendor oversight, QTA generation and auditing, including lead auditor role to evaluate partner/vendor’s Quality Management Systems, resources, premises, and equipment
Work with QA Associate Director to ensure Medison is compliant with the latest regulatory and pharmaceutical regulations and trends related to GMP and GDP
Ensure or participate in self-inspections of GMP/GDP operations and ensure identified CAPAs are closed to plan
Participate in Medison Management Review to assess QMS effectiveness and implement continuous improvements
Ensure change control requests, deviations, complaints, and CAPAs are recorded, reviewed, and completed using risk-based principles
Participate in regulatory inspections and supplier audits as required
Participate in recall and mock recall operations
Carry out other duties reasonably required and assigned by the manager
Support quality activities across the South Cluster, including Serbia, Croatia, Slovenia, Bosnia, Montenegro, and Hungary, with potential extension to other territories

Requirements

What you’ll need

Degree in science or equivalent (pharmacist is the preferred option)
At least 3 years’ experience in an active QA role in health care sector
Strong knowledge of regulatory, GDP and GMP requirements
Excellent written and verbal communication skills
Experience as quality auditor
Experience in regulatory inspections is desirable
Quality function representative on various projects
Root cause analysis and investigation skills
SOPs and other quality documents creation
Strength in critical thinking, problem solving, and decision making
Collaborative nature, self-directed and independent
Very strong organizational abilities
Fluent English