Objectives and Key Deliverables
Seeking a Quality Assurance Specialist to work on a 6 month project (can be extended to 12 months) for a pharma company in Singapore.
Planned start date: 4th April
Please apply by 17 Feb to be considered.
• Review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients.
• Disposal of the intermediates and active pharmaceutical ingredients.
• Review and approve cleaning records and procedures.
• Review and approve GMP documentation and their compliance to Quality Standards.
• Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Improve quality assurance systems, as necessary.
• Review and approve deviations. 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.
• Handle product complaints.
• Maintain current quality tracking systems and the quality metrics.
• Prepare Annual Product Record Reviews.
• Conduct internal and external audits.
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries
• Bachelor degree in Science/Chemical Engineering or related with at least 1 year pf relevant working experiences in pharmaceutical industry. Diploma holder in Science/Chemical Engineering with at least 3 years of relevant pharmaceutical experiences will also be considered
• Candidate with more than 3 years of relevant experiences will be considered for Senior QA Specialist
• Thorough knowledge of Good Manufacturing Practices, validation regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.