QMS Senior Officer

Posted 20 Days Ago
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Marousi, GRC
In-Office
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Develops, implements, and continuously improves the pharmaceutical Quality Management System in compliance with EU GMP, ISO standards, and regulatory requirements. Manages document control, audits, inspections, deviations, CAPA, change controls, QMS KPIs, training, quality risk management, and data integrity. Collaborates with Production, QC, Regulatory Affairs, and other departments to maintain compliance and drive continuous improvement.
Summary Generated by Built In

Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.

Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a QMS Senior Officer to join our team at our Marousi premises.

The QMS Senior Officer will be responsible for the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with GMP guidelines and relevant regulatory requirements. The role supports Quality Assurance activities and ensures compliance with internal procedures, regulatory standards, and company objectives.


Requirements

What you will do:

More particularly:

  • Maintain and continuously improve the QMS in accordance with EU GMP, ISO standards, and other applicable regulations
  • Manage the document control system: creation, review, approval, distribution, and archiving of controlled documents (SOPs, policies, work instructions)
  • Coordinate and participate in internal audits and regulatory inspections; support audit readiness and CAPA follow-up
  • Lead the deviation and CAPA management process: investigate deviations, perform root cause analysis, and ensure timely implementation of corrective and preventive actions
  • Oversee change control procedures to ensure proper evaluation, approval, and implementation
  • Monitor and report QMS KPIs to Quality Management; propose quality improvements where applicable
  • Support training coordination for QA and cross-functional departments related to GMP, SOPs, and QMS
  • Collaborate with cross-functional teams (Production, QC, Regulatory Affairs, etc.) to ensure QMS alignment across departments
  • Participate in quality risk management activities and continuous improvement projects
  • Ensure data integrity compliance throughout QMS processes

The ideal candidate should have:

  • Educational background in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
  • 3-5 years’ experience in Quality Management

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Broad knowledge and extensive experience on pharmaceutical quality systems
  • Extensive knowledge of European GMPs in order to be able to ensure compliance with national and European standards and legislation
  • Ability to prioritize tasks and meet deadlines
  • Effective problem solver
  • Strong initiative and creativity skills

Benefits

What you'll gain:

  • Involvement in a high-caliber, team-oriented and dynamic atmosphere
  • Exposure to challenging business issues and practices
  • Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Skills Required

  • Educational background in Chemical Engineering, Chemistry, Biological Sciences, or Pharmaceutical Sciences
  • 3–5 years of experience in Quality Management
  • Excellent written and spoken English
  • Broad knowledge and extensive experience with pharmaceutical quality systems
  • Extensive knowledge of European GMP requirements and applicable national and European legislation
  • Ability to prioritize tasks and meet deadlines
  • Effective problem-solving skills
  • Strong initiative and creativity skills
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The Company
HQ: Amstelveen
1,600 Employees
Year Founded: 1969

What We Do

Pharmathen is a research-centered, pharmaceutical company focused on developing and marketing innovative generic products and complex drug delivery technologies, aiming to provide Life Cycle Management solutions.

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