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Job Details

Location
Singapore
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-156612
Contact
Gilbert Khor
Contact email
Email Gilbert
Contact phone
65 6692 0742
Posted
2 months ago
Based in Singapore

Biotech/ Biopharmaceutical Sector

Personalized Medicine

Responsibilities:

  • 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).

REQUIREMENTS

  • Bachelor’s degree or higher in Chemistry, Biology, or related discipline.
  • Must have at least 2 years of Quality Assurance work experience in a GMP environment, preferably in the biotech or pharmaceutical industries is preferred.
  • Have experience with implementation of corrective action programs and quality inspection.
  • Good 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 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 approaches.
  • Enthusiastic, positive and resilient.


Reg No. R1443092
EBC Connect Pte Ltd
Licence no. 17C8975