Quality Assurance Compliance Senior Officer
Pharmathen, Greece
Job 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 over 250 customers in over 90 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 1,200 people from over 22 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 Pharmaceuticals offers a great opportunity for career development and is seeking to attract a Quality Assurance Compliance Senior Officer to join our Quality Assurance team at the manufacturing unit in Pallini, Attiki premises.
As a Quality Assurance Compliance Senior Officer, the ideal candidate will assure compliance to the EU cGMPs requirements and ISO standards, ensure regulatory compliance of the manufacturing activities, be responsible for the customers quality demands, play a key role in the monitoring of all GxP activities of the site and the external warehouses and coordinate the interdepartmental communications regarding quality compliance.
More particularly:
What you’ll do:
- Follow Company's Quality Policy and complies 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
- Supports Regulatory Submission of Dossier
- Manage the Dossier Regulatory Compliance check
- Communicate with customer regarding any quality queries related with the activities of the facility
- Overviews Organization and monitoring of the facilities’ activities, such as Process Validations, Cleaning Validations, Media Fill, etc.
- Evaluate the results for environmental monitoring and Utilities Validations
- Overview the production, packaging technical directives and Bill of Materials
- Overview the Product Quality Review Reports
- 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
- Operate as a trainer in basic training sessions such as GMP training, Gowning SOPs, etc.
- Ensure the implementation of the annual training schedule of the personnel and organization of the scheduled and non-scheduled training sessions
- Overview the management, archiving and notification of the main department’s processes including Change Control, CAPAs, 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
- Organize and participate leading the customer audits and authorities’ inspections and corresponding Capa Plan management
Requirements
The ideal candidate should have:
- Educational background in Chemical Engineering, Mechanical Engineering, Chemistry, Biological, Pharmaceutical sciences or other relevant sector
- 3-5 years experience in Quality Management
Job-Specific Skills:
- Excellent communication in English language (writing amp; speaking)
- Computer literacy
- Ability to prioritize tasks and meet deadlines
- Problem Solving Skills
- Deep knowledge of global legislation requirements
- Strong initiative and creativity skills
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and