Quality Assurance Release Expert

Galenicum; Esplugues de Llobregat; Presencial; EUR 42.000 - 60.000; Jornada completa

Descripción de la vacante

Galenicum invites applications for a Quality Assurance Release Expert to join our QA team in Cataluña, Spain. You will lead release activities, review CoAs, BMRs and BPRs, and ensure documentation accuracy.

The role requires GMP knowledge, 3+ years in GMP settings, and experience with QA in pharma manufacturing, plus proficiency in MS Office, SAP and TrackWise. Excellent English and Spanish are essential. This position offers growth within a fast-growing company.

Formación

• GMP knowledge and experience in GMP environments.
• Minimum 3 years’ experience in GMP environment.
• Experience in QA within a pharmaceutical manufacturing site is preferred.
• Experience with TrackWise or similar CAPA systems.

Responsabilidades

• Lead release activities by reviewing CoAs, BMR, and BPR documentation.
• Manage corrective actions and drive continuous improvement.
• Support QA agreements with customers and suppliers.
• Handle deviations, customer/supplier claims, and change controls.
• Monitor GMP regulations and ensure alignment with the Quality System.
• Participate in external audits of CMOs and follow up on CAPA plans.
• Maintain periodic customer follow-up for released products.

Conocimientos

GMP knowledge

English

Spanish

Problem-solving

Educación

Bachelor's degree in Pharmacy

Master’s degree in Pharmaceutical Industry or related

Herramientas

MS Office

SAP

TrackWise

Descripción del empleo

BELIEVE IN LIFE. Join a company that takes you further!

Galenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide.

People are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values.

Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!)

We are looking for a Quality Assurance Release Expert to join our Quality Assurance Team!

What you'll be rocking:

• Release activities, by reviewing CoAs, Manufacturing & Packaging Records (BMR, BPR) and management of documentation related.
• Proposal and management of corrective actions with focus on continuous improvement.
• Support in the review of Quality Technical Agreements with customers and suppliers.
• Management of deviations and customer/ suppliers claims.
• Management of changes, incidences and nonconformities.
• Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities.
• Participate in external audits to CMOs related to own release products, with execution of audit, review and evaluation of audit reports, CAPA plan evaluation and follow-up.
• Periodic follow-up of Customers for designed release products.

What you bring to the table:

• GMP knowledge.
• Minimum 3 years’ experience in GMP environment.
• Preferred experience in QA within a pharmaceutical manufacturing site.
• Experience in MS Office.
• Experience in SAP.
• Experience in TrackWise or similar platform.

Educational milestone:

• Preferably degree in Pharmacy.
• Master’s degree in Pharmaceutical Industry or related.
• Excellent level of English and Spanish, spoken and written.

Your key superpowers:

• Motivated, disciplined, proactive, dynamic, methodical, organized and decisive.
• Self-sufficient.
• Strong analytical and problem-solving skills.
• Strong organizational, planning and time management skills, to achieve project timelines.
• Highly responsible and capable to work under pressure to meet deadlines.
• Ability to prioritize multiple tasks.
• Detail oriented and good communication and research skills.
• Capable of working under your own initiative whilst being a good team player.
• Report redaction (risk assessment evaluation report, audit report, among others).

We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you?