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.
NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.
The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.
Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404
