Jobscope
- Ensuring Quality oversight for validation activities including Data Integrity topics.
- Implement and maintain the Quality Management System (QMS) in line with regulatory standards and company policies.
- Assist the validation team with gap analysis / risk assessment and proposed mitigating plans
- Participate in validation discrepancy investigations, assist in the review & approval of the discrepancy reports and support associated CAPA closures.
- Review and approve validation documents not limited to protocols and reports.
- Support internal and external audits, addressing audit findings and ensuring compliance.
- Investigate quality issues and lead corrective and preventive actions (CAPA).
- Participate in risk assessments and change control processes to mitigate quality risks.
- Review and approve routine SOPs, FORMs and any relevant procedures including Manufacturing Batch Records
- Handle deviations from quality standards and ensure timely resolutions.
- Drive continuous improvement initiatives to enhance operational efficiency while maintaining compliance.
Requirements:
- Min Degree in Science or equivalent with at least 2 years of relevant experience in the pharmaceutical / chemical industry.
- Experience in operating laboratory equipment such as HPLC, GC , KF Titrators.
- Working knowledge of cGMP and regulatory requirements related to Quality is an advantage
- 5 days office hours
If you are interested in the position, do kindly drop your most updated resume to [email protected]
Esther Lim Suk Hui
EA Personnel No: R18728082
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
