QA Operations Specialist
Gdańsk
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:
Key element of the role is to ensure that production and quality control areas are compliant with the rules and procedures in place at Polpharma Biologics. You will be responsible for preparation of the department documentation and revision of documentation prepared by other parties. You will be also tasked with assessment of changes, investigations, and deviations process management, and with performing of risk assessments within the assigned area. You will also perform revisions of handwritten and audit trails records referred to drug substance manufacturing process and testing.
Your responsibilities:
- Preparation and reviewing of GMP documents, including review of Batch Records;
- Assessment of the documentation both 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 internal audits;
- Participation in the processes of change control, risk analysis and deviation, including investigations and verification of the CAPA in accordance with the applicable procedures;
- Verification of production processes for compliance with GMP requirements through regular visits at the production area;
- Supporting the whole life cycle management of a manufacturing facility, up to and including GMP compliant market production;
- Supporting preparation of Annual Product Quality Reviews.
If you have:
- University degree with a specialization in the field of biotechnology, biology, chemistry, pharmacy or related;
- 5 years in a cGMP-related industry with at least 3 years of Quality Assurance experience in a cGMP environment;
- Experience within biotechnological manufacturing/research will be an advantage;
- Knowledge of GMP requirements and pharmaceutical laws and regulations;
- Knowledge of Quality Management Systems;
- Problem solving skills;
- Knowledge of the concept of data integrity including computerized systems;
- Ability to work effectively under pressure, handle multiple projects and meeting deadlines;
- Knowledge of manufacturing technology related to pharmaceutical products and analytical methods related to their assessment;
- Knowledge of regulations and guidelines for Good Manufacturing Practice (GMP) contained in ICH, FDA, EMEA and national guidelines (applies to 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;
- Working knowledge of MS Office.