[Pharma Manufacturing MNC] 1.5 Years Contract QA Specialist (Batch Record) Up 4.5K #HJC

[Pharma Manufacturing MNC] 1.5 Years Contract QA Specialist (Batch Record) Up 4.5K #HJC

Singapore | Posted: Jan 02, 2025

Position Responsibilities

• Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with quality standards and regulatory registered specifications.
• Disposition the intermediates and active pharmaceutical ingredients (API).
• Review and approve cleaning records and procedures and ensure compliance with the Quality Standards (PQS) and guidelines.
• Review and approve GMP documentation and ensure their compliance to Quality Standards (PQS).
• Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Improve quality assurance systems, as necessary.
• Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the Quality Standards (PQS).
• Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
• Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated state of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.

Education

• Bachelor’s Degree in Science/Chemical Engineering or equivalent.
• A minimum of 1-3 years’ experience in Quality Assurance role within the pharmaceutical industry.