QA Clean Utilities Validation 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 position you will be responsible for management of QA Utilities Validation Team, defining of validation requirements, planning and reporting of validation activities as well as for reviews and approvals of related documentation.
Your responsibilities:
- Deliver the quality assurance of utilities validation program consisting of entire system lifecycle
- Management of a team of QA Utilities validation professionals (approx. 3 Utilities QA Experts, main utilities areas: water systems, CIP/SIP, HVAC/gases)
- Participation in the hiring and onboarding process of new employees and external contractors
- Monitoring, training, motivating, development and performance management of QA Utilities team members
- Ensuring that the QA Utilities team members training is up to date and that the team members are competent in the roles they are assigned for
- Participation in internal and external audits through presentation of QA Utilities team deliverables to internal auditors as well as Polish and Foreign Health authorities
- Cooperating with the Head of Validation and diverse groups of production, scientific, engineering, IT and quality professionals in order to implement and maintain the validated state of Utilities systems
- Additional areas of responsibility may be added as the role may develop along with the development of the organization
If you have:
- University degree
- 10 years of overall work experience with min. 5 years of direct work experience in the area of responsibility (otherwise: relevant education and/or industry specific courses/training)
- 5 years of experience with Utilities Quality Assurance (pharmaceuticals or biopharmaceuticals, knowledge of FDA regulations and compliance)
- 2 years of experience with Team Management
- Excellent teamwork and communication sills
- Communicative English