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Quality Management System
2 weeks ago
Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.
The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.
Pharmathen's highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.
Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company's enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people's lives.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a QMS & Compliance Officer for the Quality team in our Pallini premises.
As a QMS & Compliance Officer you will be responsible for overseeing the Quality Management System (QMS) and ensuring compliance with industry standards and regulatory requirements.
More particularly:
What you will do:
- Take part in preparation, authorship/review and issuance of the Site SOPs and TDRs as well as other controlled documents of the Quality System of the company
- Conduct regular audits and inspections to monitor compliance with QMS principles and regulatory requirements as well as Regulatory compliance, identifying areas for improvement and ensuring corrective actions are implemented
- Provide training and guidance to staff on QMS procedures, compliance obligations, and quality assurance best practices
- Ensure the compliance of the Quality Management System's Requirements according to International Standard ISO 9001 and EU cGMPs
- Communicate with customer regarding any quality queries related with the activities of the facility
- Participate in multidisciplinary team for performing investigations
- Collaborate with cross-functional teams to ensure alignment on quality and compliance objectives and to foster a culture of quality across the organization
- Ownership of Document Management, Training system, Audit management including Self Inspection, Risk Management, Escalation process, Complaints management, CAPAS, as well as other Quality Management System policies, Regulatory compliance activities and Data Integrity related activities
- Active participation in SOPs and Master Records preparation/review, Deviation handling, Change Management, OOS/OOT investigations, utilities/environmental monitoring, various statistical evaluations, APQR, Process Validations, Cleaning Validations, Aseptic process Simulations, KPIs monitoring, stability oversight as well as various transfer, engineering and CSV projects and Data Integrity Campaign
- Keep a key role in customer audits and authorities' inspections and corresponding Capa Plan management
The ideal candidate should have:
- Educational background in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
- Desirable experience of 1-3 years 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
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.
