Quality Assurance Consultant

About the Role

This position focuses on running and supervising the Quality Management System (QMS) for local affiliates. The consultant ensures operations stay aligned with regulatory expectations, internal quality standards, and company procedures while overseeing quality risk, complaints, deviations, change control, CAPA, inspections, product quality review, training, local release, and GDP controls for warehousing and distribution.

Core Responsibilities

• Set up, maintain, and oversee the QMS across local affiliate operations.
• Keep the local Quality Manual and Site Master File current.
• Manage quality risks by identifying, assessing, communicating, controlling, and escalating issues when needed.
• Handle complaints as the local complaint coordinator, including reporting, initial evaluation, and investigation.
• Oversee change control, including QA review, implementation checks, and closure.
• Track and manage deviations related to internal, external, and transport-related events.
• Lead CAPA activities arising from deviations, audits, and self-inspections.
• Support authority inspections and internal self-inspections.
• Carry out local GxP surveillance and compliance assessments.
• Conduct product quality reviews.
• Administer training activities, maintain the training matrix, coordinate annual GxP refresher training, and manage LMS assignments.
• Approve local product release activities, including shipment review, goods receipt checks, and deviation follow-up.
• Monitor GDP compliance for local warehousing and distribution.
• Qualify shipping lanes and review secondary distribution transport performance.
• Review returns and assess them against return criteria in coordination with distributors.
• Manage product recalls, including execution, customer and health authority communication, reconciliation, and local destruction activities.
• Oversee GxP supplier management, including identification, qualification, approval, annual compliance review, audit planning, audit execution, and CAPA follow-up.
• Support local repackaging and relabeling through change control, protocol review, execution oversight, QA assessment, and release.

Qualifications

• A bachelor's degree in Quality Management, Life Sciences, or a closely related discipline is required.
• At least 5 years of Quality Assurance experience in the pharmaceutical or healthcare sector is needed.
• Working knowledge of GxP regulations and quality standards is essential.
• Strong analytical thinking, problem-solving ability, and communication skills are expected.
• The role requires the ability to work both independently and as part of a team.
• Hands-on experience with Quality Management Systems and Learning Management Systems (LMS) is required.

Key Competencies

• High attention to detail and accuracy.
• Strong planning, organization, and time management skills.
• Capability to lead people and manage teams effectively.
• Proactive approach with a strong focus on results.