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Sr. Spclst, Quality Assurance

MSD España

Madrid

Híbrido

EUR 40.000 - 60.000

Jornada completa

Hace 30+ días

Descripción de la vacante

A global pharmaceutical company is seeking a Senior Specialist in Quality Assurance in Madrid to support compliance with Good Distribution Practices (GDP) and serve as backup for the Quality Responsible Person. The ideal candidate has at least 5 years of quality experience in the pharmaceutical industry and a degree in pharmacy. An inclusive work environment is offered, with hybrid work arrangements.

Formación

  • At least 5 years of quality experience in the pharmaceutical industry.
  • Strong communication and teamwork skills.
  • Experience in driving results and customer management.

Responsabilidades

  • Support compliance with Good Distribution Practices (GDP).
  • Develop and align local SOPs with global quality policies.
  • Manage product quality complaints and change controls.

Conocimientos

Adaptability
Strong communication skills
Problem solving
Continuous improvement mindset

Educación

Degree in pharmacy

Herramientas

Quality Management Standards
Regulatory Compliance
Descripción del empleo

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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.

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

  • 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
  • Continuous improvement mindset
  • 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

  • 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.
  • Requisition ID R357839

    Seniority level

    Seniority level

    Not Applicable

    Employment type

    Employment type

    Full-time

    Job function

    Job function

    Quality Assurance

    Industries

    Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services

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