Lead Specialist, Quality Control (Stability)
Core
Lead stability studies and investigations to ensure medicine quality and safety standards.
Role type
Senior IC quality control specialist (stability)
Builds
Stability programs and regulatory documentation for pharmaceutical products
Domain
Life Sciences / Pharmaceuticals
Required skills
GMP compliance, stability study protocols, LIMS management, equipment maintenance, data integrity, regulatory guidelines (FDA/EMEA), validation programs
Preferred skills
Supervisory/project management, cross-functional collaboration, continuous improvement, audit participation
Technologies
LIMS
Responsibilities
Lead and author protocols and reports for stability studies and investigations; Support in-house and external product stability programs; Manage preventive maintenance and requalification of stability chambers; Troubleshoot equipment and method-related issues; Contribute to Annual Product Reviews and regulatory documentation; Participate in internal and external audit activities
Seniority
Senior, supervisory/project management