External Supply Quality Senior Officer

Posted 8 Days Ago
Be an Early Applicant
Marousi, GRC
In-Office
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Ensure cGMP and ISO 9001 compliance for external suppliers and service providers. Manage supplier qualification, audits, notifications, CAPA follow-up, risk assessments (including excipients), KPI monitoring, and supplier quality agreements. Support change control, deviations, SOPs, inspections, and customer/regulatory audits.
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 an External Supply Quality Senior Officer to join our Corporate Quality Management team at our Marousi premises.

The ideal candidate will be responsible for ensuring compliance with cGMP requirements and ISO standards.


More particularly:

What you’ll do:

  • Ensure the compliance of the Quality Management System’s Requirements according to cGMPs and International Standard ISO 9001
  • Participate in the company’s Supplier and service provider qualification program. Support the processes for selecting, qualifying, disqualifying and periodically evaluating Suppliers and Service Providers of PHARMATHEN, ensuring compliance with applicable regulations and cGxP requirements
  • Handle and monitor supplier and service provider’s complaints
  • Handle and oversee suppliers and service providers' notifications
  • Compilation, issuance and maintenance of External Supply Quality audit plan
  • Schedule of suppliers and service providers audits, support the External Supply Quality Audit Team and participate in suppliers and service providers audits
  • Follow up external Suppliers CAPA plans and their closures
  • Escalate External suppliers audit refusals to External Supply Quality upper management
  • Issuance of Third-party audit report review
  • Issue and maintain the List of Qualified External Supply Quality Auditors
  • Monitor Supplier Quality related KPIs
  • Issue and follow up the Suppliers and Service Providers Quality and Technical Agreements
  • Coordinate, conduct and maintain the risk assessment of excipients used in medicinal products, as per EU Guideline for excipients (2015/C 95/02)
  • Coordinate, conduct and maintain the external supplier risk assessment
  • Participate in the main department’s processes including “Change Control”, “Deviation Investigation Reports”, “Corrective Preventive Actions”, “Risk Management”
  • Responsible for development and review of departmental SOPs, TDRs, protocols and any other relevant controlled quality documents related to the assigned duties
  • Actively participate in Customers’ Audits and Competent Authorities’ Inspection

Requirements

Minimum Qualifications:

  • BSc / MSc in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or other relevant sectors

Minimum Experience:

  • 3-5 years of experience in Quality Management / Assurance within the pharmaceutical industry will be considered an asset

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines
  • Exceptional communication skills
  • Strong project management skills
  • Autonomous, rigorous with critical thinking

Benefits

What you will 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/ scientific 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

  • BSc or MSc in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related
  • Knowledge of cGMP requirements
  • Knowledge of ISO 9001
  • Experience in supplier qualification and audits for pharmaceutical suppliers
  • 3-5 years experience in Quality Management / Assurance within the pharmaceutical industry
  • Excellent English (written and spoken)
  • Computer literacy
  • Strong project management and prioritization skills
  • Ability to work autonomously, rigorous mindset and critical thinking
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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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