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GMP Quality Assurance Technician

On-site in Madrid·Full-time·Added 2 months ago (last checked 26 Oct)

Agency

Randstad España

5959 open roles

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Our summary

Work mode: On-site, Madrid
Contract: Fixed-term, full-time hours
Spanish: Native level
English: Required
Experience: 3+ years
Education: University degree

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Skills

This job advert was originally written in Spanish.

Requirements

What we're looking for

Minimum of 3 years of experience in a similar position for a senior role.

Experience in Quality Assurance; extensive knowledge of GMP documentation review; knowledge of SAP/R3 and MS Office; knowledge of quality systems in production plants, including procedures, training, deviations/non-conformances, complaints, and audit support.

Company cafeteria.

Education & certifications

University Degree in Pharmacy, Chemistry, Biology, or Health-related Sciences.

Languages

● Languages: Intermediate or advanced level of English and bilingual Spanish.

The role

Do you have experience as a QA within the pharmaceutical industry?

What you'll do

Review and approve API, packaging material, bulk product, and finished product release specifications.
Review and approve bulk and packaged batch records and related documentation.
Review and approve analytical data related to products and/or components and deviations/non-conformances.
Issue, review, and approve release documentation and sign certificates of analysis for batches manufactured for release or regulatory purposes in relevant markets.
Approve and/or reject product batches (bulk and finished product), raw materials, and packaging materials in SAP.
Review, maintain, and approve batch master records and their status in SAP in accordance with the marketing authorization.
Evaluate customer requirements/requests related to product documentation or registration information.
Periodically evaluate the status of bulk and packaging inventory control to determine availability after the retention time.
Support customer requests based on QTA, MAA, and/or quality issues.
Manage complaints forwarded to suppliers related to received batches.
Review and approve stability protocols.
Perform internal shelf-life reviews and external audits of third parties and/or suppliers.
Manage change controls, CAPA, and complaints.
Develop APR/PQR documentation for the different products on time.
Support official quality inspections and customer audits according to the Annual Plan, to evaluate the GMP quality system.
Manage technical quality agreements between the company and customers.
Support quality investigations and recalls.

Hiring process

2 steps1 interview

Apply to the job
Under review · With a Randstad consultant
Shortlisted
Consultant contact
With a Randstad consultant
One of our consultants will review your application and contact you about the next steps.
Company decision
With a client company
Randstad acts as an intermediary connecting candidates with companies; in some cases final handling of profiles and the decision on whom to contact rest solely with the company.

The final stages are set by the client company: final handling of profiles and the decision on whom to contact rest solely with the company.
Randstad does not publish timescales; your application status may not change because of the high volume of applications or because the company manages its own timings.
The published statuses only go as far as shortlisting: Randstad does not detail later interviews or assessments.

About Randstad España

Randstad España is the Spanish branch of Randstad N.V., a global leader in human resources and staffing solutions. The company provides a wide range of workforce solutions, including temporary and permanent placement, recruitment process outsourcing, and HR consulting. With a strong presence in Spain, Randstad España connects thousands of professionals with job opportunities across various sectors, including industrial, technical, and customer service roles.

For international professionals, Randstad España offers a gateway to the Spanish job market, with numerous openings in technical maintenance, customer service, and administrative roles. The company values diversity and inclusion, and its extensive network of offices across Spain ensures support for candidates seeking employment in different regions. Randstad's global reach and local expertise make it a reliable partner for those looking to relocate and work in Spain.