Operational Quality Assurance Expert
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role:
Ensuring that the GMP rules and the procedures are complied with across the production, the engineering and the quality control areas. The preparation of the department documentation and revision of documentation prepared by other stakeholders. Assessment of the changes to the processes and completed the investigations within the deviation management process, perform the risk assessment activities within the area of the oversight. Perform revision of the hand written record and the audit trails record for process and quality control equipment.
Your responsibilities:
- Revision of the audit trails from process and quality control equipment to ensure data integrity is maintained within computerized systems
- Preparation and reviewing of GMP documents, including review of Batch Records
- Assessment of the documentation internal and provided by the external parties
- Participation in inspections of the pharmaceutical authorities and customer audits, to the extent specified by the supervisor
- Participation in the internal audits
- Participation in the processes of change control, risk analysis and deviation, including investigations
- Verification of the corrective and preventive actions in accordance with the applicable procedures
- Verification of production processes for compliance with GMP requirements through regular visits in the production area
- Interpret and implement quality assurance standards and regulations and translate them into internal procedures
- Analyse the data to identify areas for improvement in the quality system
- Prepare reports to communicate outcomes of the quality activities
- Identify training needs and organize training interventions to meet quality standards
- Evaluate audit incompatibilities and implement appropriate corrective actions
If you have:
- Higher education in with a specialization in the fields: biotechnology, biology, chemistry, pharmacy, computer science or related
- five year (5) in a CGMP-related industry with at least three three (3) years of Quality Assurance experience in a cGMP
- Experience within biotechnological manufacturing/research will be an advantage
- Knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals in particular to regulations related to audit trial review – Annex 11 and 21CFR part 11
- Knowledge of Quality Management Systems
- Problem-solving orientation
- Knowledge in the concept of the data integrity including computerized systems
- Ability to effectively manage of working time
- Basic knowledge of the technology of manufacturing pharmaceutical products and analytical methods related to their assessment
- Knowledge of regulations and guidelines for Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines (applies to the Senior role)
- Strong verbal and written communication skills (including Polish and English languages), good time management skills; ability to interface with all levels of the organization
- Ability to work with MS Office