External Supply Quality Officer

For almost six decades, Pharmathen has remained committed to its vision of improving patients’ lives through innovation and expanding access to complex pharmaceutical therapies.

Today, Pharmathen's capabilities extend across a broad range of specialized dosage forms, including sustained-release products, long-acting injectables, and oral solid dosage forms, while its portfolio includes more than 100 commercial products available internationally through a strong network of partners.

These activities are supported by a robust Research & Development and Manufacturing ecosystem, with three facilities in Greece.

The driving force behind Pharmathen is its people. With more than 1,600 employees representing 27 nationalities, the company fosters a multicultural workplace where women account for 53% of the workforce and 40% of the Senior Leadership Team.

Grounded in its shared values of integrity, quality, innovation, leadership and performance, and guided by strong business ethics and a commitment to its vision, Pharmathen remains dedicated to its founding mission: improving patients' 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.