Ensuring all quality-related records are managed according to cGMP and other regulatory standards.
- Documentation Management, Managing, maintaining, filing, and retrieving quality-related documents, including batch records, testing results, Standard Operating Procedures (SOPs), and test certificates.
- Compliance and Audits
- Ensuring all activities align with internal policies, ISO standards (e.g., ISO 9001), and external regulatory requirements such as Good Manufacturing Practices (GMP).
- Participating in and supporting internal and external audits.
- Quality Systems Support: Assisting with the implementation and maintenance of the Quality Management System (QMS), including change control, deviations, Out-of-Specification (OOS) results, and Corrective and Preventive Actions (CAPAs).
- Inspections and Testing, coordinating and performing inspections and tests of raw materials, in-process samples, and finished products to ensure they meet specifications.
- Reporting and Analysis, creating clear reports on quality performance, analyzing data, and identifying trends or areas for improvement.
- Working with other departments (e.g., Manufacturing, R&D, Engineering) to resolve quality issues and ensure consistent quality standards.
- A Bachelor's degree in Engineering, Organic Chemistry, Pharmaceutical Engineering, or a related science field
- Relevant experience in a GMP-regulated pharmaceutical or biopharmaceutical environment, 2-3 years for an engineer role.
- Knowledge of quality management systems, documentation procedures, and relevant regulations (e.g., cGMP, ISO 9001).
Veronica Neo Shen Hwa -
[Confidential Information]
Personnel Reg No: R1110855
Manpower Staffing Services (S) Pte Ltd
EA Licence No: 02C3423
