GMP Senior Auditor

hace 3 días

Ciudad de México, Ciudad de México Rephine A tiempo completo

About Rephine

Our clients refer to us as the
Gold Standard in Life Sciences product quality
. We are global experts in Quality Assurance and GxP compliance across Pharmaceutical, Biotech, and Medical Device manufacturing supply chains.

Rephine Barcelona is part of the
Rephine Group
, with offices in Spain (Barcelona), the UK (Stevenage), and China (Shanghai), supporting clients worldwide.

Are you passionate about Pharma & Life Sciences?

Do you enjoy working in a team, conducting audits, and traveling internationally?

Are you ready to contribute to a fast-growing global company?

If so, this opportunity is for you.

The Role

We are looking for a
GMP Senior Auditor
based in
Mexico
, with the ability to conduct audits in
Mexico, the United States, and Canada
.

You will join our technical team on a full-time basis and play a key role in ensuring compliance with
GMP, GDP, GLP, and GCP
standards across pharmaceutical and healthcare facilities.

Key Responsibilities

  • Conduct on-site and remote audits of
    API manufacturers, excipient suppliers, and pharmaceutical/healthcare facilities
    .
  • Evaluate compliance with
    GxP regulations
    and identify gaps, risks, and improvement opportunities.
  • Review documentation, procedures, and quality systems, proposing corrective and preventive actions.
  • Stay up to date with
    regulatory requirements and industry best practices
    .
  • Prepare clear, accurate, and professional audit reports.

Requirements

This role is for you if you have:

  • Proven experience as a
    GMP Auditor
    within the pharmaceutical or healthcare industry.
  • Strong knowledge of
    GMP and GDP
    (knowledge of
    GLP and GCP
    is a plus).
  • Excellent analytical and critical-thinking skills.
  • Strong attention to detail and organizational skills.
  • Excellent communication and interpersonal abilities.
  • Full availability to travel internationally
    .
  • Valid visa or legal authorization to perform audits in the United States and Canada
    (mandatory).
  • Fluent English
    (additional languages are a plus).

What We Offer

  • Competitive salary
    , aligned with experience and market standards.
  • Remote working model
    , with extensive international exposure.
  • A
    multicultural and highly experienced team
    always willing to support each other.
  • Continuous
    training and professional development
    programs.
  • A strong company culture with team-building activities, social events, and Rephiesta.
  • Long-term career development in a
    growing global company
    .

Why Rephine?

For over
20 years
, Rephine has worked closely with some of the largest Life Sciences companies worldwide, supporting them directly at their facilities and helping improve manufacturing quality and compliance.

We are looking for professionals who want to
grow with us
, build a long-term career, and be part of our continued success.

Applications must be submitted in English.

Seniority Level:
Mid-Senior

Industry:
Pharmaceutical Manufacturing

Employment Type:
Full-time

Job Function:
Quality Assurance

Our recruitment process:

1) Interview with HR

2) Interview with Hiring Manager

3) Last interview

4) Offer

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