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.

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We are seeking an experienced Pharma Compliance Support Consultant in Barcelona (Spain) to support our pharmaceutical clients in ensuring compliance with integral regulatory requirements and driving continuous improvement of Quality Management Systems (QMS).

Responsibilities:

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- Manage, maintain, and improve Quality Management Systems (QMS) in compliance with GMP regulations and applicable regulatory requirements (EU GMP, FDA, ICH).

- Support clients in QMS implementation, remediation, and continuous improvement initiatives.

- Participate in internal audits, supplier audits, mock inspections, and regulatory inspections.

- Coordinate and support Validation activities, define validation strategies, acceptance criteria, and sampling plans.

- Support Technology Transfer projects between manufacturing sites and external partners.

- Participate in remediation activities resulting from inspections by regulatory authorities.





- Assist in the preparation and review of responses to regulatory observations and commitments.

- Participate in Quality Risk Management initiatives, including process risk assessments and cross-contamination risk assessments.

First Project you will be assigned to:

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- Duration of this first project: 7 months (We offer a permanent contract)

- Our offices are in Barcelona and Madrid

Requirements:

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- Bachelor's Degree in a scientific discipline such as Pharmaceutical Chemistry (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Microbiology, Pharmaceutical Sciences, or related fields.

- 3 years of experience in Quality Assurance, Quality Compliance, or Validation roles within the pharmaceutical industry and/or GMP consulting environments.

- Strong knowledge of Quality Management Systems (QMS), GMP regulations, Process Validation, and Cleaning Validation.

- Hands on support for reviewing and amending procedures/SOPs on a new aseptic process.

- Scope of the process includes Compounding and Filling machinery with Isolator.

- FDA and EU GMP knowledge is preferred and also experience in aseptic processes.

- Experience supporting inspection readiness activities and regulatory audits. xqbhyrx

- Native in Spanish and fluent in English (minimum B2 level).

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- Salary starts from 30.000€ gross per year

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📌 Compliance Support (Barcelona)
🏢 Pqe Group
📍 Barcelona