Quality Assurance Officer (Sapes)
Pharmathen, Greece
Job Description
Description
We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of hundreds of customers in over 80 countries throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.
Our portfolio consists of over 100 products, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.
We proudly employ more than 1,350 people from over 24 different nationalities across 9 locations. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision to make a difference in people’s lives through our everyday activities and our products.
Due to continuous growth and expansion, Pharmathen offers a great opportunity for career development and is seeking to recruit a Quality Assurance Officer to join our Quality Assurance team at our Sapes, Rodopi premises.
As a Quality Assurance Officer, the ideal candidate will be responsible for ensuring compliance with GMP requirements and ISO standards.
More particularly:
What you’ll do:
- Follow Company's Quality Policy and comply with current operational standards and legislative requirements
- Work in accordance with the requirements of the written Policies, Standard Operating Procedures, Technical Directives and Protocols of the company's Quality System, that are related to the duties of the described position
- Follow the rules of hygiene and control of health status as defined in the relevant Policies and Standard Operating Procedures
- Ensure the compliance of the Quality Management System’s Requirements according to International Standard ISO 9001 and EU cGMPs
- Communicate with the Regulatory Affairs Department regarding the approved information of the product
- Support Regulatory Submission of Dossier and management of Dossier Regulatory Compliance check
- Communicate with customer regarding any quality queries related with the activities of the facility
- Handle organization and monitoring of the facilities’ activities, such as Process Validations, Cleaning Validations, Aseptic Process Simulation, etc
- Evaluate and report the results for environmental monitoring and Utilities Validations
- Review the production, packaging technical directives and Bill of Materials
- Prepare and/or review of Product Quality Review Reports, trending reports and annual yields reports
- Take 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
- Ensure the implementation of the annual training schedule of the personnel and organization of the scheduled and non scheduled training sessions
- Handle 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.
- Participate in multidisciplinary team for performing investigations
- Participate in customer audits and authorities’ inspections and corresponding Capa Plan management
Requirements
The ideal candidate should have:
- BSc in Chemistry, Biology, Pharmacy, Engineering or equivalent
- Experience within a manufacturing unit / laboratory / Quality unit operating under GMP / GLP / ISO or other regulatory standards
- 1 - 2 years of experience in Quality Assurance in Pharmaceutical Industry will be considered an asset.
Job-Specific Skills:
- Fluency in English language (writing amp; speaking)
- Computer literacy
- Ability to prioritize tasks and meet deadlines
- Exceptional communication skills, strong project management skills
Benefits
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