Quality Assurance Specialist
3 days ago
Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.
They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.
**Key Points**:
- New headcount with growing, reputable pharma MNC
- 5-day work in CDB area with hybrid work arrangements, near MRT
- Overseas travelling opportunities with attractive salary and perks
**Responsibilities**:
Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.
- Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
- Monitor EMO/supplier qualification, assessment and performance evaluation processes.
- Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
- Maintain and update internal audit program.
- Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
- Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
- Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
- Provide training and guidance to quality staff on quality documentation, including system - Veeva (QMS), compliance training system etc.
- Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.
**Requirements**:
- Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
- Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
- Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
- Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
- Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
- Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
- Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404
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