Job description

As a Quality Assurance Specialist, you will play a critical role in ensuring compliance with regulatory standards and maintaining the highest quality standards in pharmaceutical operations.

Responsibilities:

• Review and approve master batch records, batch records, cleaning records, and procedures to ensure compliance with set standards.
• Ensure all GMP documentation adheres to quality procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP).
• Review and approve deviations in accordance with site procedures.
• Handle product complaints, ensuring thorough investigations and implementation of effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
• Collaborate with cross-functional teams to prepare Annual Product Reviews, analyze trends, and recommend improvement actions for atypical observations.
• Apply Six Sigma, lean principles, and process improvement tools to drive continuous improvement in quality operations.
• Conduct internal and external audits to ensure compliance with regulatory standards.
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Participate in GMP walkdowns to ensure site operations and facilities are maintained in an inspection-ready state.
• Support the maintenance of validated GMP systems and processes.
• Facilitate regulatory submissions and respond to regulatory queries in a timely manner.

Requirements:

• Bachelor’s Degree in Science, Chemical Engineering, or a related field.
• 1-3 years of relevant experience in QA/QC and GMP compliance within the pharmaceutical industry.
• Strong knowledge of GMP compliance regulations, ICH Q7a Guidelines, and Good Documentation Practices (GDP).
• Familiarity with manufacturing operations, Six Sigma, lean principles, and process improvement tools.
• Proven track record of driving continuous improvement in quality operations or manufacturing.
• Excellent attention to detail, problem-solving skills, and the ability to work collaboratively in a cross-functional team environment.

Interested candidates please apply online or send your latest CV to alex.fong@AlwaysHired.com.sg

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

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