Quality Assurance Release Expert

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 Laboratory 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 3-4 years' experience in GMP environment.
• Minimum 2 years experience in QA in a Pharmaceutical manufacturing site.
• Experience in MS Office.
• Experience in SAP.
• Experience in TrackWise or similar platform.

Educational milestone:

• Degree in life sciences, preferably 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?

Come aboard. Believe in life