Job Title: Validation Specialist
This role is responsible for establishing and documenting a risk-based validation strategy, developing and implementing validation master plans, and performing product and project validation.
* You will create validation documentation in line with guidelines, identify and integrate efficiency tracking tools, change drafts within the CAPA framework, and align proposals with stakeholders.
* You will perform complex data analyses in Excel for optimizations, assist and train other departments in problem-solving techniques, and analyze urgent and critical issues related to the product or production process.
* You will ensure knowledge retention and dissemination within the department and with other departments, and regularly report to the Managing Director.
Required Skills and Qualifications:
* You have completed a higher education in science/technology.
* You have experience in a comparable role.
* You have excellent knowledge of Microsoft Outlook, especially Word and Excel (data analysis).
* You have strong proficiency in English.
* You have a solid understanding of GMP and experience in a GMP environment.
* You have experience in root cause analysis (DMAIC, FMEA, 6M), familiarity with lean and/or six sigma is advantageous.
* You possess exceptional project management skills: creating plans, tracking activities, and promptly escalating issues/risks.
* You own excellent technical writing skills: succinctly yet thoroughly and clearly documenting information in a well-organized/structured manner.
* You have strong interpersonal skills (communicative and attentive): capable of gathering necessary information and diligently following up on actions with other departments.
* You own strong analytical skills: rapidly forming a coherent understanding and defining an action plan.
* You pay high attention to quality and detail.
About the Job:
* This role is ideal for individuals who are passionate about quality assurance and have a strong background in validation.
* The successful candidate will be able to work independently and as part of a team to achieve business objectives.
Benefits:
* A competitive salary and benefits package.
* Ongoing training and development opportunities.
* A dynamic and supportive work environment.