I am currently looking for a AS&T Lead for one of my Global Pharmaceutical MNC client. This is an exciting role to join a reputable company with their new upcoming expansion projects.
Title: AS&T Lead (Analytical Science & Technology Lead)
Type: Permanent
Salary: SGD 6,000 - SGD 8,000
Location: Singapore
Key Responsibilities:
- Own & Lead projects, often complex in nature; including direct responsibility for leading various teams to successful completion of various projects. Strong ability to manage multiple priorities.
- Own & Lead analytical method validation / verification and to ensure full compliance of introduced Microbiological and EM methods to current standards. Responsible for implementation of projects into QC laboratories.
- Work with tech transfer teams to prepare new processes; point of contact for QC/lab operations for external customers. Set-up and coordinate detailed planning and document deliverables as per Master Plan and agreed timelines by working collaboratively within QC and cross-functional teams.
- Direct customer and regulatory agency interaction as required. Involve in regulatory audits in an independent manner. Responsible for all EM topics, including disinfectant studies, EM trends, Contamination Control Strategy etc.
- Lead and approve validation documents (Example: Method Qualification / Validation / Investigation).
- Superior ability to troubleshoot all applicable methods.
- Provide trending and statistical support for periodic reporting, and or decision making.
- Support investigations for major and critical discrepancies (OOS, complaints, deviations). Make recommendation for product quality impact assessments and propose CAPA actions.
Essential Requirements:
- Degree/PhD in Biology/Biotechnology
- 8+ years of related experience in GMP-regulated industries in Quality Control.
- Must understand FDA/EMA/ICH/EU annex 1 requirements as well as industry quality systems.
- Knowledge and understanding of manufacturing and quality control. Experience in bio-technology/bioprocess/bio manufacturing is highly desirable.
- Strong analytical, planning, execution, interpersonal, communication, negotiation and problem-solving skills.
- Considerable organization awareness (e.g. inter-relationship of departments, business priorities), including significant experience working cross-functionally.
