Quality Management System Expert
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:
Are Quality Systems your natural environment? Is working at a growing biotech pharma company a challenge worth to be accepted? Have you got experience and skills to face inspections and audits of national and foreign authorities? If you answered positively to these questions, our position might be just the right next step in your career.
At this position you will assist QMS Manager in developing, implementing, and supervising operation of the Quality Management System. You will be tasked with helping in the preparations of Polpharma Biologics for pharmaceutical inspections and audits led by national and foreign authorities. You will be responsible for ensuring proper course of deviations, corrective, and preventive actions, and change controls etc. You will cooperate with Polish and foreign regulatory authorities.
Your responsibilities:
- Preparations, and reviewing of QMS documentation in regards to legal requirements, GxP, and QAA requirements
- Cooperation with the other Polpharma Biologics Departments during preparations of documentation connected with changes in regulatory dossier
- Participation in proceedings related to risk analyses, ensuring that the proceedings are in accordance with GMP regulations and internal procedures of Polpharma Biologics
- Effective cooperation with the other Departments of Polpharma Biologics and substantive support in the matters within the scope of QMS Department
- Participation in the initiated corrective and preventive actions according to the procedures in force
- Reviewing and approving investigative actions in reference to the reported deviations, OOX, complaints according to procedures in force and legal requirements
- Participation in change control processes, making sure that the proposed changes are in compliance with GMP requirements, and that the change management is in compliance with internal Polpharma Biologics procedures
- Performing duties in accordance with current GMP regulations and other pharmaceutical requirements
- Performing duties delegated by supervisor
- Ensuring timely preparations of data required for the purpose of monthly / quarterly / annual quality system reviews
- Active participation and substantial support in solving quality problems and preventing their occurrence
- Participation in organization, implementation, systematic assessment of effectiveness and improvement of the quality system in accordance with current legal requirements, including GxP, in the scope covered by the authorization for the production of medicinal products and the authorization related to import of medicinal products
- Project management in terms of the responsibilities
- Participation in processes related to suspensions and/or withdrawals of medicinal products, as well as investigational medicinal products from the market
- Participation in the preparations of Polpharma Biologics for audits and inspections
- Conducting of internal trainings in the scope of Quality Assurance and GxP for company’s employees at all levels of management
- Leading and/or participating in internal and external audits
- Developing, revision, updating, distribution and archiving of GMP documentation and Quality Assurance section documentation (in paper as well as electronic form) at Polpharma Biologics
- Revision and approval of documentation needed for technical systems in Polpharma Biologics and participation in qualification activities if needed
- Cooperation with other departments to assess the proper system for data management policies
- Supporting the Organization in achieving critical milestones
If you have:
- University degree in in biologics, chemistry, pharmacy, biotechnology, or related field
- 5 years of working experience in the pharmaceutical industry
- Knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH environment
- 5 years of working experience and knowledge of Quality Management Systems
- Knowledge of Polish would be an advantage
- Very good knowledge of English both, written and spoken
- Ability to work with MS Office
- Ability to make decisions
- Ability to work as a team member
- Communication skills
- Ability to solve problems
- Ability to perform complex tasks