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 [Confidential Information]
AlwaysHired Pte Ltd
Reg No: R1549345
EA: 24C2293
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