Overview
Quality System & Compliance Lead Jobs in Singapore, Singapore at WUXI XDC SINGAPORE PRIVATE LIMITED
Job Responsibilities:
Establish XDC Singapore site quality system, ensure it complies with FDA, EMA and PICs GMP requirement;
Continue monitor and improve site quality performance, ensure quality system being healthy running
Ensuring appropriate training is delivered to all personnel involved in GMP activities
Responsible for monitoring and assessing the changes of applicable regulations, ensuring the continuous compliance
Facilitating regular management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement;
Ensuring that a timely and
effective communication
and escalation process exists to raise quality issues to the appropriate levels of  responsible for documentation lifecycle management
Be responsible for regularly reviewing and assessing the quality metrics
Be responsible for establish Quality Risk Management Plan, ensure implementation per schedule and follow up mitigations (if any) till completion
Be responsible for product complaints handling
Be responsible for product recall if any Ensuring internal audit program is implemented at site Responsible for managing external inspection, e.g., client audit, regulatory inspection etc.
Other tasks assigned by the supervisor.
Requirements:
Bachelor degree or above, majoring in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering or other relevant majors
10+ years’ working experience in production and/or quality management in biopharma, with 8+ years in production QA or quality system QA.5+ years’ experience in team management
Be familiar with FDA, EMEA, PICS GMP requirement
Experience with
quality system set up for new site is preferred
Experience with
Biopharma commercial quality system is preferred
Familiar with quality management requirement throughout the whole product lifecycle, including process development, clinical and commercialization.
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Title: Quality System & Compliance Lead
Company: WUXI XDC SINGAPORE PRIVATE LIMITED
Location: Singapore, Singapore
Category: Quality Assurance – QA/QC, Pharmaceutical
