Quality Assurance Consultant

Shou; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company is seeking a Quality Assurance Consultant responsible for implementing and overseeing the Quality Management System (QMS) across local affiliates. This role involves ensuring compliance with regulatory requirements and managing several key quality processes. Candidates should have a Bachelor's degree, along with at least 5 years of experience in Quality Assurance, preferably within the pharmaceutical sector. Strong analytical, leadership, and communication skills are essential for success in this role.

Formación

• Minimum of 5 years of experience in Quality Assurance in pharmaceuticals or healthcare.
• Strong knowledge of GxP regulations.
• Proficient in using Quality Management Systems.

Responsabilidades

• Implementation and oversight of the Quality Management System (QMS).
• Management of quality risks and complaints.
• Training management for local staff and maintenance of training matrix.

Conocimientos

Analytical skills

Problem-solving

Communication

Organizational skills

Leadership

Educación

Bachelor's degree in Quality Management, Life Sciences, or related field

Herramientas

Quality Management Systems

Learning Management Systems (LMS)

Descripción del empleo

About the job Quality Assurance Consultant

Job Summary: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.

Key Responsibilities:

• QMS implementation, maintenance, and oversight in local affiliates.
• Maintenance of the local Quality Manual and Site Master File.
• Quality risk management in local affiliate, including risk identification, analysis, communication, control, and escalation as required.
• Complaint management, acting as the Local Complaint Coordinator for reporting, local assessment, and local investigation.
• Change control management, QA assessment, site change control, QA review for change implementation and closure.
• Deviation management for internal, external, and transport deviations.
• CAPA management from deviations, internal audits, external audits, and self-inspections.
• Management of authority inspections and self-inspections.
• Local GxP surveillance and assessment.
• Training management, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.
• Local product release (local QP), shipment review of transport performance, goods receipt check, and deviation handling.
• Oversight of GDP requirements for local warehousing and distribution.
• Shipping lane qualification and local transport performance of secondary distribution.
• Secondary distribution transport performance review.
• Return management, including QA evaluation against return criteria and collaboration with distributors.
• Product recall management, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.
• GxP suppliers management, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.
• Local repackaging and relabeling, including change management, protocol, execution, QA review, and release.

Qualifications:

• Bachelor's degree in Quality Management, Life Sciences, or a related field.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.
• Strong knowledge of GxP regulations and quality standards.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in using Quality Management Systems and Learning Management Systems (LMS).
• Attention to detail and accuracy.
• Strong organizational and time management skills.
• Effective leadership and team management abilities.