Analytical Science & Technology Lead (QC)

Reference: BH-161340

Based in Singapore
Analytical Science & Technology
Biopharmaceutical Sector

The position will get the incumbent involved and leading in the analytical technology transfer of biologics or biopharmaceutical quality control processes. The company will be relying on the incumbent in providing the technical expertise and consultation to the team on the ground.

Key Responsibilities:

Participates and supports GMP audits
Leads and manages site projects and initiatives
Keeps up-to-date on the regulations/ development concerning biopharmaceutical QC activities to ensure quality control operations are in compliance to applicable corporate, regulatory and external agency regulations and guidelines
Supports the manager to ensure knowledge retention and effective training within team
Ensures all in-use procedures are current and compliant
Writes/ reviews/ approves required GMP documentations such as SOP, protocols, reports
Writes/ reviews/ approves notifications (events and deviations) and/or CAPAs
Writes/ reviews/ approves changes (CCs)
Leads/ manages investigation of non-conformities (NC) (events and deviations)
Ensures thorough investigation and timely closure with effective CAPA to prevent recurrence
Provides guidance, support and technical expertise on quality control operations (relevant to area of responsibility) to ensure full compliance to any regulatory guidelines
Manages local compendium system
Ensure team performance and efficiency

What we are looking for:

Relevant Degree in Science (Chemistry/Biochemistry/Microbiology)
Relevant working experience in a testing laboratory or Bio/pharmaceutical environment
Technical knowledge and competencies for method validation and qualification
Technical knowledge on analytical + sampling method validation around cleaning validation
Strong analytical mind set
Good communication skills
Good knowledge of cGLP and cGMP
Proven leadership skills with good interpersonal skills and stakeholder management

R1443092

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