Quality Assurance Validation Expert
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:
- Delivery of the validation programme for cleaning, process and transport validation and sanitization/sterilization processes.
- Definition of validation requirements.
- Planning and reporting of validation activities.
Your responsibilities:
- Plan, manage, support and implement the quality assurance of process, cleaning, transport 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.
- Act as the validation owner, delivering the quality assurance of process, cleaning, transport and sanitization/sterilization processes through:
- Working with the User and the Head of QA Validation to define and execute the programme of work to deliver compliant validation programme.
- 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 to validation program of process, cleaning, transport and sanitization/sterilization processes and recommending the level of validation activities required to ensure delivery of a robust, compliant validation programme 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 programme to prevent gaps in regard to compliance.
- Ensuring initiation/preparation and closeout of all deviations, CAPA and change control TWD records related to process, cleaning, transport and sanitization/sterilization validation processes.
- Project Management of the validation campaigns incl. participation in contracting out activities and delegation of responsibilities to the team members.
- The role requires development of in-depth knowledge in the process, cleaning, transport and sanitization/sterilization 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 cleaning, transport and process validation and qualification ideally within the biotech or pharmaceutical industry.
- Experience in the pharma industry.
- Cleaning, process, transport validation and sanitization/sterilization – 2 years incl. development of validation strategies, validation process and execution.
- Fluency in spoken and written English.