A global leader in the production of natural ingredients (based
Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo.
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
Open to:
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. xohynlm
A role ideal for professionals who want to leave a tangible mark on an organisation's regulatory excellence.