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Senior QA Specialist - Belgium, Netherlands
Posted on : 04 April 2017
Senior QA Specialist
- 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 on site staff. Level of in dependency 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.
- Keeps quality oversight on validation strategy and deliverables for specific projects.
- 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.
- Master Degree in Engineering, Pharmaceutical sciences, Process Technology, or equivalent.
- 10 years of professional experience in GMP environment.
- 5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging.
- Additional experience with Non Conformance, 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 in English language.
- 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.
- 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.
- a young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- personal and professional development through guidance, education and knowledge sharing
- a competence development model focused on your personal ambitions
- an attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.