Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Validation Manager
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Validation Manager
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Establish, write and maintain the Validation Master Plan for process validation
- Support MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process procedures
- Maintain overview of validation state across sites
- Cooperate with Quality based on feedback (e.g. via regulatory inspections, changes in regulations) to establish and maintain common approach
- Develop the strategy for continued process verification (CPV) and review of the risk assessments for CPV
- Set procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments
- Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections
- Author complex validation protocols
- Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation
- Support equipment process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering
- Understand potential risk areas/shortfalls and make sure that the site validation program is always inspection ready
- Leads the validation group and is responsible for his team members
- Monitor the production processes and process quality, and make improvements as needed
- Performing all duties with respect to current GMP requirements and other pharmaceutical regulations
- Represent the company during regulatory inspections
What do we expect?
- 5-8 years of experience in manufacturing/manufacturing science and technology/technical development
- Thorough understanding of manufacturing processes (Up- & Downstream) and related process equipment
- 2-5 years of experience in executing process validation, having led and managed validation projects
- Expert in reviewing and writing technical reports
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
- Fundamental understanding of standard pharmaceutical analytical testing
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Fluent in English, willing to learn Polish language
- Flexible and adaptable
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.