Operational Quality Assurance Specialist (Junior, Specialist or Senior position)
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!
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 process and quality control equipment.
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
- Performing GMP visits in the production area / Quality Control / Warehouse
- 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
- Revision of the audit trails from process and quality control equipment to ensure data integrity is maintained within computerized systems
- 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 at the production area
- Assessment of certificates for compliance with specifications
- Interpret and implement quality assurance standards and translate them into internal procedures (applies to Senior role only)
- Collection and compilations of statistical quality data (applies to Senior role only)
- Analyse the data to identify areas for improvement in the quality system
- Preparing reports to communicate outcomes of the quality activities
- Identifying training needs and organize training interventions to meet quality standards
- Evaluating audit findings and implement appropriate corrective actions
If you have
- University degree with a specialization in the field of biotechnology, biology, chemistry, pharmacy or related
- A minimum 6 months of experience in a similar position within Quality Control, Quality Assurance and GMP regulated industry, for Junior role it will only be an advantage
- 5 years in a cGMP-related industry with at least 3 years of Quality Assurance experience in a cGMP environment (applies to Senior position)
- 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 is expected for Senior role
- Ability to work effectively under pressure, handle multiple projects and meeting deadlines is expected for Senior role
- Basic 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