Quality Assurance Specialist

PQE Group; Barcelona; In loco; EUR 32.000 - 52.000; Tempo pieno

Descrizione del lavoro

PQE Group is seeking a Quality Assurance Technician to support the QMS, ensure GMP compliance and uphold quality standards across pharmaceutical and medical device projects. You will handle QA documentation, deviations, CAPAs, supplier qualification, validation activities, audits, and regulatory support.

Ideal candidates hold a Bachelor's degree in a relevant field, at least 2 years in QA within regulated environments, and native Spanish with English at B2 or higher.

Competenze

• Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, Health Sciences, or a related field.
• At least 2 years of experience in Quality Assurance within the pharmaceutical industry or another regulated environment.
• Practical knowledge of QA processes and quality documentation within the pharmaceutical or chemical sector.
• Good knowledge of GMPs and applicable quality standards.
• Familiarity with quality management processes, including deviations, CAPAs, change controls, audits, and validation activities.
• Native Spanish is required
• English proficiency at B2 level or above.

Mansioni

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Draft, review, and update Standard Operating Procedures (SOPs) and other quality documentation.
• Support supplier and product qualification activities.
• Coordinate and follow up on calibration, qualification, and validation plans.
• Maintain personnel training records and support training program management.
• Manage and follow up on change controls, CAPAs, Out-of-Specification (OOS) investigations, complaints, deviations, and non-conformities.
• Participate in internal and supplier audits, supporting audit preparation, execution, and follow-up activities.
• Maintain and organize Quality Assurance documentation, ensuring proper record management and archiving.
• Support the execution and documentation of validation activities.
• Assist with regulatory activities and interactions with health authorities, including annual declarations, inspections, and requests for information.
• Monitor and coordinate pest control and waste management activities in accordance with applicable requirements.

Conoscenze

QA processes

GMP knowledge

Documentation

Audit support

Regulatory compliance

Formazione

Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, Health Sciences

Descrizione del lavoro

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

We are currently looking for a Quality Assurance Technician who will support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable GMP requirements, pharmaceutical regulations, and relevant quality standards.

You will work on a variety of QA processes, including quality documentation, deviation management, CAPAs, supplier qualification, validation activities, audits, and regulatory support, collaborating with internal teams and external stakeholders.

Key Responsibilities

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Draft, review, and update Standard Operating Procedures (SOPs) and other quality documentation.
• Support supplier and product qualification activities.
• Coordinate and follow up on calibration, qualification, and validation plans.
• Maintain personnel training records and support training program management.
• Manage and follow up on change controls, CAPAs, Out-of-Specification (OOS) investigations, complaints, deviations, and non-conformities.
• Participate in internal and supplier audits, supporting audit preparation, execution, and follow-up activities.
• Maintain and organize Quality Assurance documentation, ensuring proper record management and archiving.
• Support the execution and documentation of validation activities.
• Assist with regulatory activities and interactions with health authorities, including annual declarations, inspections, and requests for information.
• Monitor and coordinate pest control and waste management activities in accordance with applicable requirements.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, Chemical Engineering, Health Sciences, or a related field.
• At least 2 years of experience in Quality Assurance within the pharmaceutical industry or another regulated environment.
• Practical knowledge of QA processes and quality documentation within the pharmaceutical or chemical sector.
• Good knowledge of Good Manufacturing Practices (GMPs) and applicable quality standards.
• Familiarity with quality management processes, including deviations, CAPAs, change controls, audits, and validation activities.
• Native Spanish is required
• English proficiency at B2 level or above.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.