Ra/quality Specialist Iv

2 weeks ago

Singapore Bio-Rad Laboratories Full time

Responsibilities**:RA**
- Audit & Inspections
- Participates in regulatory agency inspections as needed and assists in dispersing the information as appropriate
- Prepares, files, and submits responses to external quality surveys, tender and questionnaires
- Manufacturing site
- Support and perform regulatory risk assessment for CAPA, QN deviations, significant/non-significant changes request. Customer complaint etc
- Involve in reviewing and approving the Quality Notifications, Document Information Records, ensure the changes are captured and documented and risks are evaluated, this is not limited to internal changes, also includes the changes initiated from suppliers or triggered by customers
- Work closely with cross-functional team such as Engineering, Production, Quality Control, etc. to ensure that regulatory processes remain relevant and compliant to applicable internal and external requirements, and provide guidance to the key stakeholders on overall regulations
- Support for compliance gap assessment and risk assessments such as FDA QSR, ISO13485, cGMP, etc
- Reviews new and revised labeling to ensure applicable domestic and international labeling requirements are met
- Recommends changes for labeling and manufacturing for regulatory compliance
- Vigilant
- Prepares and coordinates completion and filing of internal documentation required during Field Corrective Actions
- Prepares and coordinates completion and filing of internal documentation required to support Adverse Event Reporting
- Interface and collaborate with Legal Manufactures and Global Regulatory team
**QA**
- Conduct investigation and analysis of customer complaints; highlight the trends to manufacturing for improvements.
- Performance Internal Audit to identify gaps in compliance or nonconformance for the site.
- Support internal auditing activities.
- Support NPI activities from QMS perspective to ensure the smooth product transfer and the proper validations are completed prior to the transfers.
- Other duties may be assigned.

Qualifications:

- Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent preferred.
- 8+ years’ relevant experience in a regulated manufacturing industry or equivalent combination of
- Excellent communication skills
- Demonstrated proficiency and knowledge of Regulatory process and requirements for In-Vitro Diagnostic Medical Device
- Knowledge of ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives & EU IVDR.
- education and experience.
Working knowledge of device/drug/biotech manufacturing processes and knowledge of IVD MD regulations
- Detail-oriented and ability to multitask.
- Analytical, problem solving, computer, and critical thinking skills.
- Advanced technical writing and word processing skills.

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