Quality Management System Manager
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:
In this role you will assist Quality Compliance Head in developing, implementing, and supervising the operation of the Quality Management System. You will be tasked with helping in the preparation of the Unit for pharmaceutical inspection and audits led by national and foreign authorities to ensure proper course of action during deviations investigations, corrective and preventive actions implementation and change control management. You will interact with regulatory authorities.
Your responsibilities:
- Management of QMS Team
- Preparation, revision, and approval of quality documentation according to legal, GMP and QAA requirements
- Cooperation with other departments of Polpharma Biologics during preparations of documentation connected with changes in regulatory dossier
- Participation in risk analysis process, making sure if it’s in compliance with GMP regulations and that change control management is compliant with internal procedures of Polpharma Biologics
- Effective cooperation with other departments of Polpharma Biologics in scope of Quality Compliance duties
- Participation in proceeding the initiated corrective and preventive actions in accordance with the procedures in force
- Review and approval of reported deviations, OOX and complaints in accordance with the procedures in force, according to legal requirements
- Participation in change control process, making sure that proposed changes are compliant with GMP regulations and that change control management is compliant with internal procedures of Polpharma Biologics
- Performing duties in accordance with current GMP regulations and other pharmaceutical requirements
- Ensure timely preparation of data required to prepare monthly / quarterly / annual quality system reviews
- Active participation and substantial assistance 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 requirements, in the scope covered by the authorization for production of medicinal products and the authorization to imported medicinal products
- Informing the supervisor about qualitative problems, negative trends, audit observations, especially when they may affect patient safety, quality, or effectiveness of medicinal products
- Project management in terms of responsibilities
- Participating in processes related to the suspension and / or withdrawal of the medicinal product and the investigational medicinal product from the market
- Participation in the preparation for audits and inspections in Polpharma Biologics
- Conducting internal training in scope of quality assurance and GxP for company employees at all levels of management
- To lead and/or participate in internal and external audits
- Quality Agreement Management
- Internal Audits Management
- Preparation of quality contracts with service providers, providers of materials, and contract givers
- Participation in the complaint process related to suppliers of materials / services
- Development, revision, update, distribution and archiving of GMP and QA Section documentation (paper and electronic) in Polpharma Biologics
- Compliant Management
- APQR Management
- Change control process management
- Review of batch records of drug substance, product in bulk, medicinal product and IMP, and confirmation of manufacturing stages
- Release and rejection of drug substance, product in bulk, medicinal product or IMP
- Participate in communication with the Sponsor or Product Owner, in the process of withhold and recall of the medicinal product or IMPs and in investigation following from product complaints
- Making independent decisions about Investigational Medicinal Product batch
- Support the Organization in achieving critical milestones
If you have:
- Higher education in biologics, chemistry, pharmacy, biotechnology or related
- 5 years of working experience in the pharmaceutical industry, including 2 years in the evaluation of pharmaceutical products in the scope of quality control and quality assurance
- Knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH environment
- Knowledge of Quality Management Systems
- Fluent English
- Ability to work with MS Office
- Ability to make decisions.
- Ability to work as a team member and a team lead
- Excellent communication skills
- Ability to solve problems
- Ability to perform complex tasks
- Experience with building, developing and managing a team.
- Organizational skills and the ability to work under pressure
- Eligibility to act as a Qualified Person
Poznaj
Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.