Are you passionate about quality and precision? Join our client with your validation expertise and help ensure top-tier standards every day.
À±½·ÊÓƵ is seeking a QC Validation Specialist to support quality control and validation activities within a pharmaceutical or biotechnology setting. In this role, you will act as a subject matter expert (SME) in testing methodologies, troubleshooting technical issues, and driving method improvements. This position involves cross-site coordination, regulatory input, and the development of new testing methods. The role is hybrid, requiring three days in the office.
Responsibilities:
- Maintain compliance with QC method validation lifecycle requirements.
- Lead troubleshooting investigations and resolve technical challenges related to QC test methods.
- Provide SME guidance for method standardization and robustness programs.
- Develop and improve current and new test methods, staying updated on the latest testing technologies.
- Coordinate and execute intra-site method transfers and contribute SME input to regulatory filings and audits.
- Design experiments for projects involving new technologies and processes in QC.
- Manage and oversee Analytical Science and Technology (AST) studies.
- Review validation data, identify trends or deviations, and escalate concerns to management.
- Plan and manage method validation, development, and transfer activities, influencing QC leadership on improvement strategies.
- Stay informed about industry advancements in methods, equipment, and techniques.
- Identify and implement improvements that positively impact the business.
Key Skills and Requirements:
- Strong background in microbiology and biochemistry.
- Experience with plate readers and associated software is a plus.
- Ability to troubleshoot and resolve technical issues effectively.
- Familiarity with regulatory requirements and quality systems (e.g., CAPA, Change Control).
- Strong project management and coordination skills.
- Excellent communication and collaboration abilities.
If you are having difficulty in applying or if you have any questions, please contact Pamela Phoumavong at p.phoumavong@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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