Quality Assurance Specialist / Biotech

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

1. Compile quality metric data required for management reporting and prepare sections of quality metric reports.
2. SOP writing and issuance for site qualification and validation project as and when needed.
3. Identify deviations and potential risks in manufacturing systems, processes and methods, and their possible causes.
4. Implement validation processes to review systems, methods and processes utilised in manufacturing facilities.
5. Access impact to validation for changes that occur during the project and define appropriate validation requirements and approach to meet these requirements.
6. Identify potential compliance risk and gaps and recommend improvements.
7. 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.
8. Handling site change control and deviation with other counterpart to meet the project timeline.
9. Ensure compliance of site Safety, Health & Environmental (SHE) requirements.

EXPERIENCE REQUIREMENTS

• More than 5 years in a Bio-Lifescience environment, candidate with MNC, Large Organizations or GMP experience will have an advantage.
• Working understanding of Lab/GMP Operations, QC, QA, Process Development, Supply Chain and related functions.
• Involvement in setting up New Site and/or Project Management will be an added advantage.
• Foundational understanding of ICH Q7,Q8, Q9, FDA 21 CFR, Eudralex, PIC/S cGMP guideline.
• Applicant with knowledge in supply management and vendor management will have an advantage.
• Position and Title will be accorded per work and/or industry experience of the candidate.
• Self-starter, self-motivated – effective in being individual contributor and team player with other Functions.
• Able to speak/read/write Chinese.
• Candidate with start-up experience will have added advantage.

Working location:

-Tai seng

Working days & hours:

Mon-Fri, 9.00am-6.00pm