Singapore, Singapore, Singapore

Quality Assurance Officer

 Job Description:

The post holder will join a multi-discipline team tasked with the development and manufacture of novel cell and gene therapy products. The Quality Assurance (QA) Officer will be taking part in managing the site quality system, evaluate supplier and performing gap analysis in ensuring the products meet the international Good Manufacturing Practice (GMP) standards including reliability, usability and performance.

Reporting Line: Head of Quality
Collaboration: Quality Control Officers,the Production Scientists, the Molecular and Cell Biologist, and Process Development Scientist to ensure products produced meet the international GMP regulatory standards and quality expectations.

The QA Officer will be expected to have an oversight on the site's GMP compliance and to actively initiate and taking part continuous improvement programs and to Healthy and Safe Working Environment.

THE ROLE:
  • Execute and maintain the Quality Assurance systems to support batch release and GMP auditing, training, validation/qualification and revalidation/requalification program.
  • Review manufacturing batch records, test records, and data forms.
  • Review protocols, reports, and clinical data transfers.
  • Write and review SOPs.
  • Administer, review, follow-up internal/external Deviations, investigations and Corrective and Preventive Action (CAPAs).
  • Trend and report Quality systems related information (deviations, investigations CAPAs, etc.), and prepare and compile statistical quality data for updates and project status reports on site's quality performance in Quality review.
  • Conduct audits (Internal, Vendors, Suppliers, Sub-contractors Testing Facilities, and Clinical).

THE PERSON:
  • Bachelor's degree or higher in Chemistry, Biology, or related discipline
  • At least 3 years of Quality Assurance work experience in a GMP environment, preferably in the biotech or pharmaceutical industries
  • Experience with implementation of corrective action programs and quality inspection
  • Strong working knowledge of the PIC/S GMP Guidelines, US Code of Federal Regulations (CFR), European Union (EU) regulations, and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
  • Knowledge of quality management tools (including Lean Six Sigma), concepts and methodologies of QA would be an advantage
  • Strong written and interpersonal communication skills, and the ability to work independently and as part of a team.
  • Attention to detail.
  • Self-motivated driven individual and goal oriented
  • Ability to think laterally with good problem-solving skills through evidence-based approached
  Required Skills:

Deviations Usability GMP Gap Analysis Oversight Six Sigma Quality Management Assurance Analysis Biology Validation Reliability Chemistry Continuous Improvement Forms Auditing Quality Control Quality Assurance Inspection Manufacturing Regulations reporting Records Vendors Suppliers Testing Communication Training Management

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