Senior Validation Specialist

The Skeye; Madrid; Presencial; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

A global leader in natural ingredients is seeking a GMP Validation & Compliance Specialist in Vigo, Spain. This role requires expertise in GMP consulting, validation, and an understanding of regulatory compliance for pharmaceutical excipients. The selected candidate will lead the transition towards full GMP compliance, conducting gap analyses, and supporting validation processes. Ideal candidates should have relevant experience, a degree in Chemical Engineering or related fields, and be fluent in English. Join this multinational organization to make a significant impact in a strategic project.

Formación

• Proven experience in GMP implementation and compliance in the pharma industry.
• In-depth knowledge of IPEC-PQG GMP for Excipients.
• Fluent in English, able to convey complex guidelines effectively.

Responsabilidades

• Lead a full GAP analysis against GMP requirements for excipients.
• Evaluate and improve current operations for GMP certification.
• Develop and execute the Validation Master Plan for processes.

Conocimientos

GMP implementation

Regulatory analysis

Risk assessment

Technical recommendations

Quality documentation

Educación

Degree in Chemical Engineering

Degree in Biotechnology

Degree in Pharmacy

Descripción del empleo

Overview

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 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

Open to senior external consultant specialising in GMP certification, or in‑house GMP Validation & Compliance Specialist.

Location

Vigo, Spain