Quality Assurance Compliance Senior Officer (Rodopi)

Σάπες, Ροδόπης
Μόνιμη
Πλήρης Απασχόληση

Πριν 1 μήνα
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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 Quality Assurance Compliance Senior Officer to join our Corporate Quality Management team in our Sapes premises.As a Quality Assurance Compliance Senior Officer the ideal candidate will ensure compliance of all activities of the facility and warehouses with the EU cGMP requirements and ISO standards, as well as customers’ demands. He / she will keep a key role in the interdepartmental communication regarding the regulatory compliance of the facility as well as the Capa Plans of the facility related to customer audits and Authorities Inspections.More particularly:What you will do:

Ensure 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
Overview the organization and monitoring of the facilities’ activities
Take part in preparation, authorship and issuance of the Site SOPs and TDRs as well as other controlled documents of the Quality System of the company
Follow and support the internal procedures related to Customer Audits and Inspections, Self Inspection, Monthly Oversight, Data Integrity, CAPA procedure, KPIs Monitoring and reporting, Escalation procedure, Pest Control
Handle monitoring, archiving and notification of the main department’s processes including Internal Audits, Data Integrity and QA Oversight, Escalation Management etc.
Support customer audits and authorities’ inspections
Support the preparation through-out the customer audits and health authority inspection
Support the preparation of customer CAPA plan and Health Authority CAPA plans, communicates internally with departments for the on-time implementation of the action plans and supports customer communication related to the above and any other request related to documentation

RequirementsThe ideal candidate should have:

Educational background in Chemical Engineering, Mechanical Engineering, Chemistry, Biological, Pharmaceutical sciences or other relevant sector
Minimum 3 years’ experience in 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

BenefitsWhat 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.

Pharmathen