Product Quality Lifecycle Supervisor
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 Product Quality Lifecycle Supervisor to join our Quality Assurance team in our Pallini premises.
As a Product Quality Lifecycle Supervisor, the ideal candidate will be responsible for ensuring that all products meet the company's quality standards and specifications.
More particularly:
RequirementsWhat you will do:
- Collaborate with the quality control team to ensure that all products are tested and meet established quality standards before release
- Implement and monitor inspection and testing processes to identify and address any deviations from product specifications
- Lead investigations into product defects, determine root causes, and implement corrective actions to prevent recurrence
- Identify opportunities for improving product quality and lead initiatives to enhance production processes and reduce defects
- Ensure all products comply with cGMPs, relevant industry standards and regulatory requirements, to support product release
- Maintain detailed records of quality control activities and prepare reports on product quality performance for management review
- Work closely with production, R&D, and supply chain teams to ensure quality standards are integrated throughout the product development and manufacturing processes
- Provide training to staff on quality standards, and industry best practices
- Take ownership of activities related with Process Validation, Cleaning Validation, OOS/OOT investigations, various statistical evaluations, various studies, APQR and stability oversight
- Actively participate in SOPs and Master Records preparation/review, Deviation handling, Complaint management, Document Management, Training system, Audit management including Self Inspection, Risk Management, Escalation process, KPIs monitoring, Change Management, CAPAS, Aseptic process Simulation, utilities/environmental monitoring, as well as other Quality Management System policies and site quality operations oversight and Data Integrity Campaign, as well as various transfer and engineering projects
- Keep a key role in customer audits and authorities' inspections
The ideal candidate should have:
- Minimum a BSc Degree in Chemical Engineering, Chemistry, Biological or Pharmaceutical sciences
- At least 5 years of experience in product quality management
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
- 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
- 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.
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