This is an IT support group | Quality Assurance Specialist
1 day 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 and medical device 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, ensuring adherence to relevant international regulations, guidelines, and industry practices alongside company compliance requirements.
Perform internal and external audits (supplier or EMO/CMO) 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 processes for audit findings to be resolved and all change implementations to be fulfilled within defined targeted datelines in compliance with GMP and company SOPs.
Ensure proper records and documentation in accordance with regulatory guidelines such as GMP documents, site master files, quality manual, and agreements.
Establish and maintain QMS to ensure content compliance with all regulations and company practices, overseeing Validation QA.
Provide training and guidance to quality staff on quality documentation, including systems such as Veeva (QMS), compliance training systems, etc.
Collaborate with the quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.
Requirements:
Bachelor's degree in Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
Minimum of 5 years of experience in the pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
Experience in auditing, especially with managing overseas EMO/CMO/third-party manufacturing experience is highly preferred.
Strong knowledge of GMP, computer system validation, deviation management, CAPA, change control, and documentation management in a pharmaceutical/medical device MNC environment.
Demonstrate proactiveness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
Proven track record 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 the time of offer 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
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