*NEW* Contract Quality Specialist / Validation Specialist (Pharma MNC, Up to $7800) #HCL

*NEW* Contract Quality Specialist / Validation Specialist (Pharma MNC, Up to $7800) #HCL

Singapore | Posted: Nov 01, 2024

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

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)