Quality Support, Specialist
(12 month contract)
About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission
Primary Responsibilities:
The role will ensure and maintain high standards of quality and compliance within client’s organization.
In this role, you will be responsible for all or subset of the key responsibilities below:
- Perform laboratory system lifecycle management, including system qualification/retirement, commissioning/decommissioning, calibration and maintenance, system administration, and periodic reviews, in accordance with approved procedures and standard lead time.
- Raise Computerize Maintenance Management System (CMMS) request form to create/update/delete SAP master data related to laboratory system.
- Raise purchase request and perform orders confirmation and accrual for laboratory system lifecycle management, inventories, maintenance and repairs orders.
- Liaise with vendor to ensure contractor management documentation and assigned vendor tasks are completed within assigned lead time.
- Perform and review of Quality documents such as eshopfloor logs, eVal and etc.
- Assist in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.
- Provide inputs for the development and revision of Standard Operating Procedures, Work Instructions and other GMP documents.
- Maintain proper laboratory/storage area housekeeping/5S and ensure inspection readiness.
- Execute section and Quality improvement initiatives and other special projects.
- Any other duties as assigned by reporting manager
- Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
- Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency.
- Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with other site and above-site functions. This includes actively participating in discussions, sharing expertise, and providing input to ensure alignment and consistency across the organization.
- Support Reporting Manager in planning of routine operations tasks to ensure completion within stipulated timeline.
- Support and respond to audit requirements and findings.
- Perform assessments of compendial updates and implement changes to Standard Operating Procedures, Work Instructions and other GMP documents.
Requirements:
- Diploma or Bachelor’s degree in Science/ Life Science, Pharmaceutical Science or Engineering or any other relevant field
- At least 3 years of relevant working experience in GMP environment with quality control laboratory experience within the pharmaceutical/chemical manufacturing.
- Competency in analytical chemistry tools such as HPLC, root cause analysis methods and tools.
Reg No: R22104540
EA License no: 94C3609
