Senior Quality Assurance Engineer
1 week ago
**Position Summary**
- The Quality Assurance Specialist implements validation processes to identify deviations and potential risks in the CMC, QC and related processes.
- You are responsible for first-line verification of quality standards in the organisation and supports the product release and registration process by collaborating with other departments to gather relevant information.
- In addition, you assist in audits, handles quality queries, delivers quality-related training, and is responsible for ensuring that documents are organised and managed according to standard procedures and requirements.
- The Quality Assurance Specialist communicates with internal and external customers on QA-related enquiries and develops practical solutions to implement workflow improvements and enhance department operations.
- The Quality Assurance Specialist is meticulous and systematic in carrying out the tasks, and exercises critical and analytical thinking to identify discrepancies in processes and resolve problems.
- The position applies communication and teamwork skills to interact effectively with others to achieve organisational objectives.
**Essential Job Functions**
- Compile quality metric data required for management reporting and prepare sections of quality metric reports.
- SOP writing and issuance for site qualification and validation project as and when needed.
- Identify deviations and potential risks in manufacturing systems, processes and methods, and their possible causes.
- Implement validation processes to review systems, methods and processes utilised in manufacturing facilities.
- Access impact to validation for changes that occur during the project and define appropriate validation requirements and approach to meet these requirements.
- Identify potential compliance risk and gaps and recommend improvements.
- Review and approve the validation deliverables related to Facility/Utilities/equipment, computerized system (automation) as well as laboratory equipment/system, further to ensure compliance with company procedures, regulatory requirements and cGMP expectations and meeting project schedule.
- Handling site change control and deviation with other counterpart to meet the project timeline.
- Ensure compliance of site Safety, Health & Environmental (SHE) requirements
Pheeraphat Jirotmontree
Reg No: R1107890
Talent Focus Pte Ltd
EA License: 22S1209
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