Quality Assurance Specialist

1 day ago

Singapore CELLVEC PTE. LTD. Full time
Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team at CellVec PTE. LTD.

Overview

As a Quality Assurance Specialist, you will be responsible for ensuring the quality and integrity of our products and processes.

Key Responsibilities:

  • Microbiology and Biochemical Product Testing: Perform EM such as active air sampling, surface and passive air samplings, plate readings and inspection of cleaned facility and sterilised equipment; Responsible for planning, monitoring and approving microbiological testing; Perform method Qualification, validation and product testing (e.g. sterility and endotoxin) to support QC lot release; Perform stability testing of released final products as per protocol and timelines; Support assessment of certification/accreditation and services provided by external labs for QC testing.
  • Documents, Records and Data Management: Drafting and updating of Standard Operation Procedures (SOPs) and specification documents for EM, equipment, sampling plan, test methods, final products and raw/packaging materials; Author and review technical protocols and reports (e.g. EM risk analysis), develop guidelines and standard practices for data documentation, analysis and training; Review test results, document data and produce trends (e.g. EM) in an efficient, organised and presentable manner to facilitate discussions, support business and performance metrics reporting.
  • Deviations, Change Control and Audits Management: Support deviations (e.g. test OOS, EM excursion) initiation, investigations and root cause analysis for product defects and quality lapses; Support change control and CAPA implementation; Support internal and external audits/inspections.
  • Equipment and Lab Management: New equipment commissioning support (Operational qualification-OQ, Performance qualification- PQ); Monitor and schedule equipment calibration and maintenance as per schedule and site master file; Perform lab housekeeping, lab cleaning and biohazard/waste management; Perform monitoring and procurement of lab inventory, for e.g. materials and consumables.
  • Continuous Improvement: Implement initiatives to encourage improvement of QC procedures, activities and workflows; Conduct routine literature review through established publication channels to ensure continual knowledge proficiency on both GMP and current technological trends relevant to CellVec's activities.

Requirements

  • Bachelor's degree in Microbiology, Biochemistry, or related field.
  • Minimum 3 years of experience in Quality Control, preferably in a biotechnology industry.
  • Strong understanding of GMP regulations and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficiency in MS Office and ability to learn new software applications quickly.

What We Offer

  • A competitive salary of SGD $60,000 - $80,000 per annum, depending on experience.
  • A comprehensive benefits package, including medical, dental, and life insurance.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

Contact Us

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