Sr. Spclst, Quality Assurance

Job Description

About the Role

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 company’s 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.
• Drive continuous improvement activities.

What You Bring :

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

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 world’s 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 :

Hazardous Material(s) :

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

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