QA 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, utilities validation and computerized systems 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.
- Work with the User (QC and Manufacturing departments), the Qualification and the Head of QA Validation to define and execute the programme of work to deliver compliant validation programme.
- Assist with the development of system requirements and specifications to ensure that the requirements are testable and that the relevant regulatory requirements are met.
- Evaluate proposed strategy and/or proposed changes to validated systems and recommend 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.
- Identify and qualify all systems which impact cGMP operations using a risk based methodology to deliver validation programme to prevent gaps in regard to compliance.
- Ensure initiation/preparation and closeout of all deviations, CAPA and change control records.
- 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.
- 3 years incl. development of validation strategies, validation protocol and execution.
- Fluency in spoken and written English.