Sr. Spclst, Quality Assurance

MSD de España; Madrid; Híbrido; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Madrid is seeking a Senior Specialist in Quality Assurance to support Good Distribution Practices. This role includes leading quality assessments, managing complaints, and acting as a QRP backup. Candidates should have a pharmacy degree and at least 5 years of quality experience in the pharmaceutical industry. A hybrid work model is offered.

Formación

• At least 5 years of quality experience in the pharmaceutical industry.
• Proven track record in quality assurance.

Responsabilidades

• Support compliance with Good Distribution Practices (GDP).
• Develop local SOPs aligned with global quality policies.
• Lead quality risk assessments and batch inspection reviews.
• Handle product quality complaints and change controls.
• Act as QRP backup and liaise with authorities.

Conocimientos

Strong communication skills

Teamwork

Problem solving

Driving results

Customer management

Educación

Degree in pharmacy

Herramientas

cGMP Regulations

GAMP

Jira

SQL

Descripción del empleo

An amazing opportunity has arisen for a Senior Specialist in Quality Assurance to support the Quality Responsible Person (QRP) in managing activities related to Good Distribution Practices (GDP) within the Spanish market. This role also involves serving as the backup to the QRP and acting as their deputy.

What you will do :

• Support compliance with Good Distribution Practices (GDP) and our companys Quality Manual guidelines.
• Develop and align local SOPs with global quality policies.
• Lead quality risk assessments and manage batch inspection reviews.
• Handle product quality complaints change controls and customer license reviews.
• Lead self-inspections CAPA plans investigations and the Quality Council.
• Support the QRP during audits and Health Authorities inspections.
• Provide training on GDP and local procedures.
• Coordinate mock recalls and approve related documentation.
• Manage daily department tasks and attend supply-related meetings.
• Act as QRP backup liaising with authorities on quality and supply issues.

What You Bring :

In order to excel in this role you will more than likely have :

• At least 5 years of quality experience in the pharmaceutical industry
• Degree in pharmacy
• Driving results
• Strong communication and teamwork skills
• Customer and supplier management
• Problem solving

Why Join Us

As a company we are committed to Inventing for Life in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So if you are ready to take on a challenging and rewarding role in Quality Assurance please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status : Regular

Relocation : VISA Sponsorship :

Travel Requirements :

Flexible Work Arrangements :

Hybrid

Shift :

Valid Driving License :

Required Skills :

Adaptability cGMP Regulations Change Management Deviation Management Good Automated Manufacturing Practice (GAMP) IS Audit Management Process Manufacturing Quality Control Pharmaceutical Quality Assurance Product Disposition Quality Assurance (QA) Quality Auditing Quality Management Standards Quality Standards Regulatory Compliance Risk Management Self Motivation Strategic Planning

Preferred Skills :

Job Posting End Date :

07 / 31 / 2025

• A job posting is effective until 11 : 59 : 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Required Experience :

Senior IC

Key Skills

Test Cases,SQL,Quality Assurance,Agile,TFS,Jira,Software Testing,Test Automation,Cucumber,QA / QC,SDLC,Selenium

Employment Type : Full-Time

Experience : years

Vacancy : 1

Quality Assurance • Madrid, Madrid, Spain