45 минут назад
Manager Quality Control I (Analytical Testing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager Quality Control I (Analytical Testing) (GMP pharmaceutical and biotechnology analytical testing): Leading raw material, utility, in-process, release, and stability testing with an accent on laboratory operations, analytical methods, compliance, and people management. Focus on method validation and transfer, OOS/OOT investigations, inspection readiness, and improving laboratory performance through Lean initiatives.
Location: Singapore Manufacturing - Tuas
Company
is a biotechnology company developing and manufacturing medicines for patients with serious illnesses.
What you will do
- Lead daily analytical testing for raw materials, utilities, in-process controls, product release, and stability programs.
- Manage laboratory resources, staffing, workload prioritization, capacity planning, and testing schedules.
- Provide technical oversight for analytical methods, instrumentation, laboratory systems, and facilities.
- Review and approve analytical records, investigations, deviations, CAPAs, change controls, and quality documentation.
- Lead analysts and senior analysts through coaching, training, performance management, and development planning.
- Support method validation and transfer, new product introduction, technology transfers, audits, inspections, and continuous improvement projects.
Requirements
- Doctorate, or a relevant master's degree with 2 years of directly related experience, bachelor's degree with 4 years, or diploma with 8 years.
- Minimum 5 years of Quality Control Analytical Operations experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Experience managing people or leading teams, projects, programs, or resource allocation.
- Strong knowledge of GMP production, laboratory operations, data integrity, computerized laboratory systems, and analytical equipment.
- Practical experience with HPLC/UPLC, GC/HS-GC, FTIR, UV-Vis spectroscopy, Karl Fischer titration, TOC, conductivity, pH testing, capillary electrophoresis, and compendial testing.
- Experience with biologics analytical techniques such as ELISA, cell-based bioassays, host cell protein testing, and potency assays, plus strong communication and problem-solving skills.
Culture & Benefits
- Collaborative work with global Quality Control networks and cross-functional teams.
- Opportunities for professional development and continuous learning.
- Support for professional and personal growth through development opportunities and company benefits.
- Medical checks required for the job scope are arranged with related expenses covered by the company.
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