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Quality Assurance Manager – 12-month Contractor
Medison Pharma. Participate in designing, implementing, maintaining, and improving the quality system .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) with a strong focus on regulatory compliance, including GMP and GDP standards. Proven ability to conduct audits, manage SOPs, and implement continuous improvements while supporting multiple territories.
Highest-signal resume keywords
Quality Management Systems (QMS)Good Manufacturing Practices (GMP)Good Distribution Practices (GDP)Quality AuditingRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SOP CreationRoot Cause AnalysisRisk-Based PrinciplesCAPA ManagementRegulatory Inspections
Soft Skills
Excellent Communication SkillsCritical ThinkingProblem SolvingOrganizational AbilitiesCollaborative Nature
Industry Keywords
Quality AssuranceHealth Care SectorVendor ManagementSelf-InspectionsContinuous Improvement
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 quality and business needs
- Participate in the GxP vendor management program, vendor oversight, QTA generation, and auditing, including serving as lead auditor
- Evaluate partner/vendor Quality Management Systems, resources, premises, and equipment
- Ensure compliance with the latest regulatory and pharmaceutical regulations and trends related to GMP and GDP
- Ensure and participate in scheduled self-inspections of GMP/GDP operations and planned CAPA closure
- Participate in Management Review to assess QMS effectiveness and implement continuous improvements
- Ensure change controls, deviations, complaints, and CAPAs are recorded, reviewed, and completed using risk-based principles
- Participate in regulatory inspections and supplier audits
- Participate in recall and mock recall operations
- Carry out other duties reasonably required and assigned by the manager
- Support the South Cluster, including Serbia, Croatia, Slovenia, Bosnia, Montenegro, and Hungary, with potential extension to other territories
- Support several territories as a member of the EPM QA team and report to the Quality Assurance Associate Director, EPM
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
Benefits
Comp & perks- 12-month contractor role
- Remote/hybrid work arrangement