QA Specialist

1 week ago

Singapore LION TCR PTE. LTD. Full time

The QA Specialist is responsible for supporting development, implementing and managing the Quality Management System (QMS) to meet operational requirements according to cGMP. Your responsibilities include support implementing QA policies, audit preparation, conducting inspections, manage deviation, CAPA and root cause analysis, drive change control and support in OOS closure.

**Responsibilities**:

- To assist the Quality Team Lead and cross functional team in all quality assurance tasks.
- Assist in the development of quality assurance programs for cross functional departments.
- Asist to review documents per the internal procedural requirement.
- Identify areas for improvement in the areas of facility management, operation, laboratory management, personnel management, training management, documentation and other related QMS systems.
- Communicate with other supervisors and managers from other departments for activities such as line clearance, scheduling of relevant activities related to training arrangements for new joiners and existing employees.
- Support in document filing and management of document archival system.
- To aid in all aspects of QA activities related to internal, external audit, supplier audit.
- Ensure all third party agreements of service providers are appropriate documented, and renewed timely.
- Assist to ensure that all GMP related documents are reviewed within its target date.
- Responsible to issue GMP documents to operation and research departments as per the documentation control procedure.
- Maintains and tracks change management records and its status in excel.
- Maintains and tracts corrective and preventive actions record and its status in excel.
- Maintains and tracks deviation management records and its status in excel.
- Maintains and update master list of documents, equipments, utilities, agreements and etc as necessary.
- Prepare trends for QMS, and provide reporting of results to the team lead.
- Performs other duties as assigned by the team lead.

**Requirements**:

- Biotechnology relevant degree with Professional experience (3 to 6 years) in managing and conducting Quality Assurance functions in GMP environment. Fresh graduates will be considered.
- Strong project management skills.
- Excellent data collection and analysis skills.
- Strong interpersonal and communication skills.
- Meticulous in planning and execution.Certification in quality assurances is a plus.

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