Are you passionate about quality and precision? Join our client with your validation expertise and help ensure top-tier standards every day.
Proclinical 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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.
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