QA Validation Specialist
What are your responsibilities?
- Perform QA support and oversight for equipment, automation and IS validation. This function does not develop the technical solutions.
- The QA validation specialist will work under supervision of qualified staff on site. Level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc)
- Expectation is that staff can perform selected QA validation activities within one month from starting date.
- Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
- Maintain a close contact and familiarity with local Quality systems
- Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
Who are we looking for?
- University or Bachelor degree in Pharmaceutical sciences, Process Technology, Engineering or equivalent
- 3 years of professional experience in GMP environment
- Relevant experience in Equipment and Automation Validation
- Additional experience with Non Conformances, CAPA’s and Change Control
- Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
- Good attention to detail and excellent writing skills
- Effective communication skills at multiple levels and areas (inside and outside of Quality)
- Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.
- Problem Solving
- Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
- Works under minimal direction
- Work is guided by operational and project objectives
- Manages multiple assignments and processes
- Independently determines approach to project
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.