PharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated QA Validations Expert to join our team.
Position Title: QA Validations Expert
Location: Madrid, Spain
Type of Contract: Full-Time
Position Summary
The QA Validations Expert is responsible for leading validation activities across manufacturing, laboratory, and computerized systems. This role ensures compliance with GMP standards, regulatory requirements, and internal quality policies, contributing to the integrity and reliability of pharmaceutical operations.
This position may require travel lasting two to three months.
Key Responsibilities
- Review and approve validation protocols (IQ/OQ/PQ/PPQ) for equipment, facilities, utilities, cleaning, and processes as well as FAT and SAT.
- Ensure compliance with FDA, EMA, ICH Q7/Q8/Q9/Q10, and other applicable regulations.
- Perform risk assessments and gap analyses to support validation strategies.
- Collaborate with cross-functional teams (Engineering, Manufacturing, QC, IT) to coordinate validation activities.
- Maintain validation master plans and ensure timely execution of validation lifecycle documentation.
- Manage deviations and non-conformances related to validation and propose corrective and preventive actions.
- Evaluate the impact of proposed process/product changes (Change Management).
- Support internal and external audits, providing validation documentation and responses.
- Train personnel on validation procedures and regulatory expectations.
- Review and approve manufacturing procedures and technical changes.
- Propose and implement improvements to enhance Quality System robustness and best practices.
Qualifications
- Bachelors or masters degree in pharmacy, Chemistry, Biotechnology, Engineering, or related field.
- Minimum 5 years of experience in pharmaceutical QA qualifications and validation.
- Strong knowledge of GMP, GDP, and regulatory guidelines (FDA, EMA, WHO).
- Experience with equipment, cleaning, processes, and computer system validation.
- Proficient in writing technical documentation and validation protocol and reports.
- Excellent communication, analytical, and project management skills.
- Fluent in English (written and spoken); other languages are a plus.
Preferred Skills
- Experience with FDA and EMA compliance.
- Familiarity with validation software tools and electronic documentation systems.
- Knowledge of data integrity principles and ALCOA+ framework.
- Systemic vision, strong analytical skills, and attention to detail.
- Results-oriented.
- Ability to manage multiple projects and prioritize tasks effectively.
- Excellent communication and negotiation skills (synthesis and presentation of ideas).
- Ability to collaborate effectively with cross-functional teams.
- Adaptability: Ability to thrive in a dynamic and fast-paced environment.
What We Offer
- Competitive salary.
- Opportunities for professional development and training.
- Dynamic and collaborative work environment.
- Contribution to high-impact pharmaceutical projects.
Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of Engineering and Quality in the Pharmaceutical Industry, we encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.
PharmEng / Efor is an equal opportunity employer and welcomes applicants from all backgrounds.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.