Quality Assurance Manager – 12-month Contractor

🔥 15 hours ago

🇸🇮 Slovenia – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Logo of Medison Pharma

Medison Pharma

501 - 1000 employees

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

Medison Pharma is a global pharmaceutical company focused on providing access to highly innovative therapies to patients in international markets. The company has pioneered an international commercialization platform aimed at facilitating the accessibility of novel treatments, thereby saving and improving lives. Medison Pharma has established a strong history of multi-territorial partnerships with leading pharmaceutical and biotech companies to help expand their global reach.

📋 Description

• 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

• 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

• 12-month contractor role • Remote/hybrid work arrangement

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