Qureos Mentor

ALKU

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 Analytical Method Establishment Scientist
 
 
 
 
 Overview:
 
 
 
 A mid-sized pharmaceutical company is seeking a skilled
 
 Method Establishment Scientist
 
 to support the implementation and training of
 
 High Voltage Leak Detection (HVLD) instrumentation
 
 . This individual will be responsible for establishing methodologies, drafting technical documentation, and training laboratory personnel to ensure successful adoption of HVLD technology within the organization.
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Lead method establishment and execution of testing using HVLD instrumentation for container closure integrity testing (CCIT).
 </li>
 <li>
 Train and mentor laboratory staff and quality team members on the proper use, maintenance, and troubleshooting of HVLD equipment.
 </li>
 <li>
 Draft and revise SOPs, protocols, and reports related to HVLD operations and CCIT methodologies.
 </li>
 <li>
 Collaborate with Quality and Laboratory teams to ensure compliance with regulatory expectations and internal standards.
 </li>
 <li>
 Provide technical expertise in CCIT methods and support validation activities as required.
 </li>
 <li>
 Ensure documentation is complete, accurate, and audit-ready.
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 <ul>
 <li>
 Strong background in
 
 Quality and Laboratory operations
 
 within the pharmaceutical or biotech industry.
 </li>
 <li>
 Hands-on experience with
 
 HVLD instrumentation
 
 and CCIT methods is required.
 </li>
 <li>
 Proven ability to draft SOPs, protocols, and technical reports.
 </li>
 <li>
 Experience training and mentoring technical staff.
 </li>
 <li>
 Strong understanding of cGMP and regulatory compliance requirements.
 </li>
 <li>
 Excellent communication and documentation skills.
 </li>
 </ul>
 
 
</div>

Analytical Method Establishment Scientist

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Analytical Method Establishment Scientist