Product Quality Life Cycle Officer (Rodopi)

DescriptionFounded 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 Life Cycle Officer to join our Quality Assurance department in our Sapes premises.The Product Quality Life Cycle Officer will be responsible for assuring compliance of all activities of the facility and warehouses with the EU cGMP requirements and ISO standards, as well as, customers’ demands.More ParticularlyWhat you’ll do:Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPsCommunicate with the Regulatory Affairs Department regarding the approved information of the productSupport Regulatory Submission of Dossier and management of Dossier Regulatory Compliance checkCommunicate with customer regarding any quality queries related with the activities of the facility and product life cycleEvaluate of the facilities’ activities, such as Process Validations, Cleaning Validations and other activities related to product life cycle and prepares respective reportsPrepare Protocols for Process Validation, cleaning Validation, etc. and ensure implementation and complianceParticipate in shop floor validation activities and ensure complianceEvaluate the results for environmental monitoring and Utilities Validations as well as the corresponding overall reportingAssist in preparation or/and review of the production, packaging technical directives and Bill of MaterialsPrepare or/and review of Product Quality Review ReportsCollect data for preparation of Product Quality Review Reports and perform statistical analysisTake part in preparation, authorship and issuance of the the Site SOPs and TDRs as well as other controlled documents of the Quality System of the company along Product Life cycleAssist in monitoring, archiving and notification of the main department’s processes including “Change Control”, “Corrective Preventive Actions”, “Risk Management”, “Deviation Investigation Reports, Complaints, OOS results, OOT results, Internal Audits, Data Integrity and QA Oversight, Escalation Management etc. and evaluates resultsCollect KPIs data of the facility and report them to Corporate quality managementParticipate in multidisciplinary team for performing investigationsParticipate in customer audits and authorities’ inspections and corresponding Capa Plan managementRequirementsThe ideal candidate should have:Educational background in Chemical/Mechanical/Production Engineering, Pharmacy, Chemistry, Biological, or other relevant sector1-3 years’ experience in Quality Management will be considered an assetJob-Specific SkillsExcellent communication in English language (writing & speaking)Computer literacyAbility to prioritize tasks and meet deadlinesExceptional communication skills, strong project management skillsBenefitsWhat you'll gain:Involvement in a high-caliber, team-oriented and dynamic atmosphereExposure to challenging business issues and practicesGreat opportunity to leverage and develop your business knowledge and skillsJoin 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.