JOB DETAILS:
Job Description:
We are currently seeking a diligent and detail-oriented Quality Assurance Officer to join our client in the pharmaceutical industry. As a QA Officer, you will be responsible for ensuring that all products and processes adhere to quality standards and regulatory requirements. Your role will be vital in maintaining the integrity of our products and in upholding our commitment to producing safe and effective pharmaceuticals.

Key Responsibilities:
1. Quality Compliance: Monitor and ensure compliance with all relevant regulations, guidelines, and industry standards for pharmaceutical manufacturing and quality control.
2. Documentation Management: Maintain accurate and organized documentation related to quality control processes, including batch records, standard operating procedures (SOPs), and quality testing data.

3. Batch Release: Review batch records and associated documentation to ensure that products meet quality specifications before release for distribution.
4. Quality Audits: Participate in internal and external quality audits to assess compliance with regulatory requirements and identify areas for improvement.

5. CAPA Management: Contribute to the identification and implementation of Corrective and Preventive Actions (CAPA) in response to quality issues, deviations, and non-conformances.

6. Root cause and investigation: Identify the gaps or deviations in the system and follow up to ensure that they are resolved.

7. Change Control: Review and assess proposed changes to processes, equipment, or procedures to determine their potential impact on product quality and compliance.
8. Supplier Quality: Collaborate with suppliers and vendors to evaluate their quality systems and ensure the quality of incoming raw materials and components.
9. Quality Training: Assist in the development and delivery of quality-related training programs for employees to enhance their understanding of quality principles and practices.

10. Product Complaints: Investigate and analyze customer complaints related to product quality and work with relevant departments to implement corrective actions.
11. Validation Activities: Support validation activities, including equipment qualification, process validation, and cleaning validation, to ensure that processes are capable of consistently producing quality products.
12. Risk Assessment: Participate in risk assessment activities to identify potential quality risks and develop strategies to mitigate them.
13. Continuous Improvement: Contribute to the continuous improvement of quality systems by identifying opportunities for streamlining processes and enhancing efficiency.

Qualifications:
• Bachelor’s degree in Medical/Pharmacy/Biomedical Engineering or related fields.
• Strong information retrieval and data analysis skills, as well as excellent official document writing abilities；
• Strong resilience, ability to face challenges and adapt to new things.
• Previous experience (3+ years) in quality assurance within the pharmaceutical or related industry.
• Familiarity with pharmaceutical regulations and guidelines, such as Good Manufacturing Practices (GMP) and International Council for Harmonisation (ICH) guidelines.
• Strong attention to detail and analytical skills to assess quality data and trends.
• Experience with quality management systems and documentation practices.
• Problem-solving abilities to address quality issues and implement appropriate solutions.
• Knowledge of risk assessment and root cause analysis methodologies.
• Certification in Quality Management or Quality Assurance is desirable.

• Application letter
• CV/Resume with at least 3 referees
• Academic documents