Quality Assurance Release Expert

Galenicum; Cataluña; Presencial; EUR 42.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Flexible schedule

Training program Galenicum Laude

Meal subsidies

Gym facility

Buddy program

Descripción de la vacante

Galenicum is seeking a Quality Assurance Release Expert to join our Quality Assurance Team. You will oversee release activities, review CoAs, BMR/BPR, and manage documentation to ensure GMP compliance.

You will drive corrective actions, support QA reviews of QTA with customers and suppliers, manage deviations and CAPA, and stay up to date with GMP regulations. English and Spanish fluency required.

Formación

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

Responsabilidades

• 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.

Conocimientos

GMP knowledge

Educación

Bachelor's degree in Pharmacy or related field

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 2-3 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:

• Bachelor's degree in Pharmacy or related field.
• 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).

What makes Galenicum a top-tier workplace?

• A challenging company, and a dynamic team to work with.
• A Workspace to enjoy. Pleasant, sustainable, and architecture-awarded office.
• A flexible schedule to match your preferences and workload.
• A training offer to learn beyond your job with a broad set of topics: Galenicum Laude.
• Health insurance coverage to feel cared.
• Food to keep your energy up. Subsidized meals in our office restaurant Popina.
• Gym to help you maintain a healthy lifestyle.
• Flexible remuneration.
• And, very important! A Buddy to help you land smoothly in our company since day 1.

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

Come aboard. Believe in life