What's on Offer
- Possibility to develop in organisation that has stable situation on the market
- Possibility to influence strategical decisions within whole production plant
- Help in relocation with package
- Medical insurance for family
- Co-financing of meals
- Co-financing of the Multisport card
- Wellness program
- Pension program for employees
- Life insurance
- Co-financing of a kindergarten
- Lead and ensure the implementation and maintenance of the QMS and Act as owner for the local QMS process management related systems, review, approve QMS procedures, work instructions and other quality documents escalated to his level.
- Supervise the deployment of new Quality projects with the aim to improve overall factory performance and foster the implementation of global initiatives.
- Ensure audit readiness including the planning and implementation of inspections assuring risk-free evidence package for regulatory inspection whenever applicable, as well as related remediation activities.
- Support the coordination of audit program. Develop and maintain an internal auditor pool and transfer knowledge of this process.
- Lead the management review process and assist the local management to ensure that the management systems remain suitable, effective and aligned with the factory objectives.
- Manage and develop a motivated and skilled team to ensure performance levels, professional development and achievement of objectives. Develop and drive the execution of a skill matrix and training path for each role.
- Prepare and seek management approval for department budget based on factory objectives to ensure optimal allocation of resources, adequate funding, and compliance with financial practices.
The Successful Applicant
- University degree in Biological sciences, Physical sciences, Chemical Engineering or equivalent skills through demonstrated experience
- 5 -10 years' experience in Quality Assurance in Pharmaceutical, Medical Device or Food sectors
- Advanced knowledge of QA standards (ISO 9001, ISO 17025,ISO 18001, ICH, GLP)
- Experience in managing regulatory inspection as front/back room person (Principally FDA and/or other regulatory bodies) - is a must
- Knowledge on pharmaceutical and/or medical device industry regulations would be considered as an additional asset
- Project Management and Change Management skills
- Excellent client-facing communication abilities, critical thinking and problem solving skills
- Strong capacity to influence and coach, action driven, organization savvy
- Fluent in English and desirable Polish, both written and spoken