Senior Validation Specialist

The Skeye; Vigo; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading global producer of natural ingredients in Vigo, Spain, is seeking a GMP Validation & Compliance Specialist. The role involves leading compliance efforts, conducting GAP analysis, and developing validation strategies to ensure GMP certification. Ideal candidates will have proven experience in GMP implementation within the pharmaceutical or biotech industry, along with a degree in a related field. This position offers the opportunity to significantly influence the company's regulatory excellence in a multinational setting.

Servicios

High-impact strategic project leadership

Multidisciplinary international work environment

Direct influence over GMP-compliant area design

Formación

• Proven experience in GMP implementation within pharmaceutical or biotech industry.
• In-depth knowledge of IPEC-PQG GMP for Excipients.
• Experience in equipment qualification, process and cleaning validation.

Responsabilidades

• Lead a full GAP analysis against GMP requirements.
• Provide technical recommendations for layout redesign.
• Develop and execute the Validation Master Plan.

Conocimientos

GMP implementation

Regulatory interpretation

Risk assessment

Validation Master Plan

Educación

Degree in Chemical Engineering, Biotechnology, Pharmacy or similar

Accredited training in GMP or validation

Descripción del empleo

A global leader in the production of natural ingredients (based Vigo, Spain ) is launching a strategic project to certify part of its manufacturing operations under Pharma Grade GMP standards . To accelerate this transformation, we are seeking a GMP Validation & Compliance Specialist with strong experience in pharmaceutical excipients, GMP consulting, or validation roles in highly regulated environments.

This position offers a unique opportunity to join a multinational organization and lead the transition towards full GMP compliance for a new production area.

🌟 Role Overview

The selected professional will act as the key technical and regulatory expert guiding the company through all steps required to achieve GMP certification. You will analyse current operations, identify necessary improvements, and support the design, validation and documentation processes required to meet international standards such as IPEC-PQG , EU GMP , and FDA / ICH guidelines.

This role is ideal for someone who enjoys applying regulatory knowledge to real industrial environments and who can translate complex guidelines into practical, efficient solutions.

🔧 Key Responsibilities

• Lead a full GAP analysis against GMP requirements for pharmaceutical excipients.
• Interpret and apply IPEC-PQG guidelines , EU GMP , FDA CFR 21 Part 210–211, and relevant ICH standards.
• Conduct risk assessments for processes and define the “last point of purification” .
• Provide technical recommendations for layout redesign , product and personnel flows, contamination control, HVAC, zoning and clean finishes.
• Develop and execute the Validation Master Plan : IQ / OQ / PQ, process validation, cleaning validation and utilities qualification.
• Define, update and implement the quality documentation system (SOPs, batch records, deviations, CAPA, traceability).
• Collaborate with Engineering, Production, Quality and Maintenance to ensure smooth project execution.
• Support audit preparation and early interactions with potential certifying bodies.
• Estimate costs, resources and project timelines for implementation.

🎯 Ideal Candidate Profile

Required Experience

• Proven experience in GMP implementation , validation or compliance within :
• Pharmaceutical or biotech industry
• API or pharma excipients manufacturing
• Or as a consultant specialising in GMP certification
• In-depth knowledge of IPEC-PQG GMP for Excipients .
• Ability to interpret regulatory requirements and convert them into operational improvements .
• Experience in :
• Equipment qualification (IQ / OQ / PQ)
• Process and cleaning validation
• Validation of utilities (water systems, compressed air, etc.)
• Quality documentation and audit readiness

Education

• Degree in Chemical Engineering, Biotechnology, Pharmacy , or similar.
• Additional accredited training in GMP or validation highly valued.
• Fluent English .

💼 Type of Position

• Senior external consultant specialising in GMP certification, or
• In-house GMP Validation & Compliance Specialist
• Location : Vigo, Spain

🚀 What We Offer

• The chance to lead a high-impact strategic project within a global company.
• Direct influence over the design and implementation of a new GMP-compliant production area.
• A multidisciplinary, international work environment.
• A role ideal for professionals who want to leave a tangible mark on an organisation’s regulatory excellence.