AS&T Team Lead - Quality Laboratory Services (AS&T Team Lead QLS)
On-site · Târgu Mureş, Mureș County, Romania
Job Summary
Lead the Analytical Science & Technology function by directing method development, validation, transfer, and lifecycle management for raw materials, intermediates, and finished products; serve as SME for HPLC/UPLC/GC, spectroscopy, dissolution and related testing; provide guidance on troubleshooting, OOS, deviations, investigations, and method performance; ensure methods are robust, compliant with GMP/ICH/FDA/EMA; coach and develop a team of analysts; collaborate with Manufacturing, QC, QA, R&D, Regulatory Affairs and other stakeholders; review analytical documentation; drive continuous improvement, CAPA effectiveness, data integrity, and digitalization.
Required Qualifications
- Bachelor’s, Master’s, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline
- 3+ years of experience in analytical sciences within the pharmaceutical, biotechnology, or related regulated industry
- Proven experience in analytical method development, validation, transfer, troubleshooting, and lifecycle management
- Strong technical knowledge of analytical techniques such as HPLC, UPLC, GC, dissolution, spectroscopy, and physicochemical testing
- Good understanding of GMP, ALCOA+ data integrity principles, ICH Q2, ICH Q14, and relevant FDA, EMA, and regulatory expectations
- Experience with laboratory systems such as LIMS, Empower, Chromeleon, and computerized systems in a regulated environment
- Previous leadership, supervisory, or people management experience is strongly preferred
- Fluency in Romanian and English language
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