Total 3 quality assurance job vacancies in Singapore

Mission Description:

• Oversee Quality compliance in validation processes, with an emphasis on Data Integrity.
• Collaborate with Subject Matter Experts to conduct gap analyses and risk evaluations prior to qualification efforts.
• Participate in investigations of validation discrepancies, aiding in the review and approval of discrepancy reports and ensuring CAPA closures.
• Review and authorize various validation documentation, such as protocols and reports.
• Provide assistance and solutions for validation-related inquiries and challenges.
• Evaluate and approve routine SOPs, forms, and other relevant documents, including Manufacturing Batch Records.

Profile Requirement:

• Background in Quality Assurance or Quality Control within a regulated setting.
• Familiarity with validation processes and principles of Data Integrity.
• Strong analytical and problem-solving capabilities.
• Excellent communication and collaborative skills.
• Can start by November.

Mission Description:

• Review and authorize the release of products and raw materials to ensure compliance with Quality standards.
• Provide Quality oversight during the manufacturing process to ensure adherence to established protocols.
• Conduct GEMBA walks and GMP inspections to assess compliance and identify areas for improvement.
• Revise, review, and approve various procedures, including SOPs, forms, and Manufacturing Batch Records to ensure accuracy and regulatory compliance.

Profile Requirement:

• Experience in Quality Assurance or Quality Control within a regulated industry.
• Strong understanding of product and raw material release processes.
• Familiarity with Good Manufacturing Practices (GMP) and continuous improvement methodologies.
• Excellent attention to detail and communication skills.

Job Description:

• Review and approve electronic batch records to ensure compliance with regulatory standards
• Identify and address discrepancies or errors in electronic batch records
• Collaborate with production and quality teams to resolve issues related to electronic batch records
• Conduct internal audits of electronic batch records and document findings
• Provide training on electronic recordkeeping practices to relevant personnel
• Contribute to continuous improvement initiatives related to electronic batch record processes
• Maintain electronic record management systems and ensure data integrity

Requirement:

• Bachelor's degree in a relevant field (e.g., pharmaceutical sciences, chemistry, biology)
• Knowledge of regulatory requirements related to electronic batch records in the pharmaceutical industry
• Strong attention to detail and analytical skills
• Excellent communication and collaboration abilities
• Ability to work effectively in a team environment
• Prior experience in a pharmaceutical or related industry is a plus