Quality Assurance Senior Engineer
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 1,300 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 Senior Engineer to join our Quality Assurance team at the manufacturing unit in Pallini, Attiki premises.
As a Quality Assurance Senior Engineer, the ideal candidate will ensure compliance of equipment, processes and plant areas to EU cGMPs and ISO requirements, be responsible for organizing new areas and equipment projects as per quality demands and for customer communication regarding engineering topics and interdepartmental communication and play a key role in all calibration/qualification activities.
Requirements
More particularly:
What you’ll do:
- Follow Company's Quality Policy and comply with current operational standards and legislative requirement
- 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.
- Responsible for issuance of TDR and SOPs relevant to operation, maintenance, cleaning and validation/ qualification activities of areas and equipment
- Ensure compliance with legislation requirements regarding change controls, deviations, risk management related to equipment and areas
- Ensure compliance to the Quality Management System according to ISO 9001:2015 and EU cGMPs
- Responsible for the preparation and control of the controlled layouts of the plant and the warehouses
- Responsible for issuance, conducting and monitoring of protocols, that will be used for validation and / or qualification of equipment, warehouse and production areas
- Keep key role in project plans regarding new areas and equipment and has the main role for internal and subcontractors communication
- Design, develop, execute, monitor and control the internal Validation/Qualification procedures of the equipment/premises, utilities and production areas and evaluate findings of measurements and studies, according to legislation and company’s standards
- Design, develop, executes, monitor and controls the Validation/Qualification procedures provided by external parties, for the equipment/premises, utilities and production areas and evaluate findings of measurements and studies, according to legislation and company’s standards
- Responsible for the training of production, warehouse and technical personnel related to the controls measurements with regards to validation amp; qualification of equipment and plant areas
- Monitor the environmental conditions of production, quality control and warehouse areas as well as utilities
- Monitor the maintenance activities of the facility and the external warehouses
- Keep key role in all calibration/ qualification activities of the site and the external warehouses
- Maintain basic role in troubleshooting regarding technical issues of the site and the external warehouses
- Keep key role in customer audits and authorities’ inspections and corresponding Capa Plan management
The ideal candidate should have:
- BSc in Engineering or relevant field
- 3 - 5 years’ experience in calibration/ qualification sectors
Job-Specific Skills:
- Excellent communication in English language (writing amp; speaking)
- Computer literacy
- Ability to prioritize tasks and meet deadlines
- Problem Solving Skills