Quality Assurance Validation 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 responsibilities:
- Plan, manage, support and implement the quality assurance of equipment and systems (e.g. clean utilities and HVAC) qualification and sanitization/sterilization validation program consisting of entire system lifecycle (from URS, through implementation, changes to system retirement) in order to ensure compliance with relevant regulatory requirements and industry guidelines. Cleaning and process validation is a nice to have.
- Act as the QA validation owner, delivering the quality assurance of changes for new implementations or improvements to existing systems/processes.
- Working with the User and the Head of QA Validation to define and execute the program of work to implement compliant validation changes.
- Assisting with the development of system requirements and specifications to ensure that the requirements are testable and that the relevant regulatory requirements are met.
- Evaluating proposed strategy and/or proposed changes with validation impact and recommending the validation strategy required to ensure delivery of a robust, compliant validation program meeting regulatory requirements and industry best standards, both in start-up and sustained operations.
- Identifying and qualifying all systems which impact cGMP operations using a risk based methodology to deliver validation program to prevent gaps in regard to compliance.
- Ensuring initiation/preparation and closeout of all deviations, CAPA and change control records related to validation topics.
- The role requires development of in-depth knowledge in the validation processes and validation management through:
- Developing in-depth industry knowledge and following industry trends to ensure a high standard of the quality assurance in order to meet the relevant regulatory requirements.
- Continuous development through internal and external training as well as developing relevant knowledge in their own capacity.
- The role requires to be able to manage and accommodate change, be able to work with people and to be assertive to achieve the outcome.
- Additional areas of responsibility may be added as the role may develop along with the development of the organization.
If you have:
- University degree in a science/ engineering (biotechnology, biology, pharmacy or equivalent).
- Experience in validation and qualification ideally within the biotech or pharmaceutical industry.
- At least 5 years experience incl. development of validation strategies, validation process and execution.
- Nice to have: experience in Computer System Validation of automated systems, such as experience in cleaning and process validation.
- Fluency in spoken and written English.
We offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more.
