QM Medical Device Senior Officer

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 QM Medical Device Senior Officer to join our Corporate Quality Management team at our Marousi premises.

The QM Medical Device Senior Officer is involved in all stages of medical devices’ lifecycle used in combination products. Particularly provides input from development including user requirement capture, change management, risk assessments and assessments of suppliers’ activities up to the transfer to manufacturing sites and extended to lifecycle of the product.

More particularly:

What you’ll do:

• Participate in the development of a quality management system for medical devices and combination products in accordance with applicable standards and regulations, ISO 13485, EU MDR regulation and US-FDA 21 CFR Part 4 and 820 and provide leading assistance in the preparation for company certification if necessary
• Ensure that the quality management system remains up to date, covering the current requirements of the above legislation relating to the combination of products and medical devices
• Provide assessment and support R&D and rest involved departments in quality management issues related to combination products and medical devices
• Participate in supplier audits whether it is necessary providing input in the compilation of the audit report
• Participate in audits/ inspections performed by customers, authorities and notified bodies supporting tasks related to combination products and medical devices
• Represent cQM and monitors the effectiveness of quality management tools in R&D and rest involved departments projects
• Answer to customer enquiries around medical devices and regulations for quality-relevant topics
• Communicate with medical device suppliers to monitor their changes and support the evaluation of the impact of such changes to company’s combination product
• Assist in response to Audit observations related to QMS activities of medical device/ combination products
• Assist in the development of documentation and record resulting from quality management system activities and according to established procedures including DHF
• Develop and adhere to strict project timelines
• Actively participate in multiple customer projects to support submission and launch preparation in different markets and communicate with suppliers for any specific requirement
• Participate in supplier evaluation processes reviewing and commenting on relevant documentation
• Participate in the review of Development/ Supply/ Quality Agreements and provide input
• Participate in the review of DHF documentation compiled by R&D Device Team

Requirements

Minimum Qualifications:

· BSc/ MSc in Engineering, Chemistry, Pharmaceutical Sciences or another relevant sector

Minimum Experience:

· Minimum 3 years of experience in Quality Management/ Assurance within the pharmaceutical industry preferred

Job-Specific Skills:

• Good understanding of quality regulations ISO 9001, ISO 13485, and MDR will be considered an asset
• Fluency in English language (writing & speaking)
• Computer Literacy
• Ability to prioritize and meet deadlines
• Exceptional communication skills
• Strong project management skills

Benefits

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

J