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Analytical Instrumentation Expert
2 weeks ago
The role of a Qualification Specialist involves ensuring the accuracy and reliability of analytical instrumentation used in scientific processes. They play a vital part in verifying that instruments meet regulatory requirements and industry standards.
Key Responsibilities:- Conduct qualification assessments on analytical instruments to ensure they meet regulatory and industry standards.
- Develop and execute qualification protocols for analytical instruments, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Collaborate with cross-functional teams to align on qualification processes and requirements.
- Maintain accurate documentation and records of qualification activities.
- Troubleshoot issues during qualification and implement corrective actions.
- Stay updated on industry trends, regulations, and best practices related to analytical instrumentation qualifications.
- Provide technical expertise to internal teams on instrument qualification and maintenance.
- Continuously improve qualification processes to enhance efficiency, accuracy, and compliance.
- Bachelor's or master's degree in chemistry, Analytical Chemistry, or a related field with 10+ years of experience.
- Solid understanding of analytical instrumentation principles and technologies.
- Proven experience in qualifying and validating analytical instruments like HPLC, GC, UV, FTIR, KFT, Balances, etc.
- Knowledge of software validation, software operation of CDS like Empower, Chromeleon, etc.
- Familiarity with relevant regulatory requirements and standards, such as FDA regulations and GMP guidelines.
- Strong analytical and problem-solving skills with ability to troubleshoot and resolve issues.
- Excellent documentation and record-keeping abilities with attention to detail.
- Effective communication and interpersonal skills with ability to collaborate and liaise with cross-functional teams.
We offer a dynamic work environment where you can apply your skills and knowledge to make a real impact. You will have the opportunity to work with a talented team of professionals who share your passion for science and quality.
About This Role:This is an exciting opportunity to join our team as a Qualification Specialist. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
