Quality System Specialist

1 week ago

Central Singapore Emprego SG Full time

**Location**
- Singapore, Central Singapore**Job Type**
- Permanent**Salary**
- $5,000 - $7,500 Per Month**Date Posted**
- 3 hours agoAdditional Details

**Job ID**
- 107288**Job Views**
- 1Roles & Responsibilities

**Job Descriptions**
- Support for compliance gap assessment and risk assessments such as FDA QSR, ISO13485, cGMP, etc.
- Evaluate Quality System issues and procedural compliance. Determine appropriate escalation process as required and take necessary action (s).
- Work closely with cross-functional team such as Engineering, Production, Quality Control, etc. to ensure that QMS processes remain relevant and compliant to applicable internal and external requirements, and provide guidance to the key stakeholders on overall QMS regulations.
- Conduct investigation and analysis of customer complaints; highlight the trends to manufacturing for improvements.
- Support the Quality Awareness campaign for maintaining the high level of quality culture to employees, includes deliver the QA induction to new hires, conduct GMP training, etc.
- Collect and evaluate KMI metrics to identify performance improvement opportunities, e.g. CAPA, Internal Audit, Change Control, Complaints, CoPQ, etc.
- Support the overall Change Control Management, 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.
- Performance Internal Audit to identify gaps in compliance or nonconformance for the site.
- Support NPI activities from QMS perspective to ensure the smooth product transfer and the proper validations are completed prior to the transfers..

**Job Requirements**
- Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent preferred.
- Minimum 5 years of experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Familiar with Quality Systems, including but not limited to investigations, qualifications, validations, CAPA, and NC.
- Working knowledge of device/drug/biotech manufacturing processes.
- Detail-oriented and ability to multitask.
- Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
- Advanced technical writing and word processing skills.
- Excellent communication skill.
- Proficiency in use of engineering tools - FMEA, SPC or equivalent statistical tools, etc.
- Knowledge of ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives.
- Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.

Tags

quality

system

specialist

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