Job Responsibilities:
Perform quality compliance and Audit related activities within the APAC and China region Established Pharmaceuticals including clinical development to ensure safe, efficacious and quality products can be supplied in accordance to regulatory and business requirements.
Working with the regional QA organization to provide support and guidance regarding document management, training, metrics and management review ensuring compliance with regulations and Quality System requirements. This position is responsible in day to day activity and to support implementation and management of quality systems and training programs, as necessary.
Manage on-site audits and quality questionnaires, related to Suppliers and Third-Party Manufacturers that fall under the responsibility of EPD Regional QA. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third-party manufacturers who provide intermediate/final products to EPD APAC & China regions.
Core Job Responsibilities:
Quality System Compliance
General Compliance Support:
· Provide comprehensive compliance support across APAC and China sites, as well as commercial affiliates.
· Lead initiatives to enhance compliance capabilities within the region.
· Continuously streamline and simplify compliance processes to improve efficiency.
Training:
· Develop and deliver training materials as needed. Maintain and update training matrices for assigned staff.
· Collaborate with Corporate Functions, representing APAC and China in corporate training initiatives.
· Administer and support the training management system, ensuring its effectiveness and compliance.
Documentation Management:
· Oversee the coordination and review of new and revised procedures, ensuring thorough impact reviews post-approval and post-obsolescence.
· Develop and deliver relevant training materials.
· Represent APAC and China in corporate document management initiatives.
· Administer and support the documentation management system, ensuring compliance and efficiency.
eQMS Management:
· Create and deliver training materials for the electronic Quality Management System (eQMS).
· Represent APAC and China in corporate initiatives related to Trackwise management and usage.
· Administer and support the Trackwise system, ensuring effective use and compliance.
Quality Audit:
· Conduct internal and regional audits for both internal and external sites, including commercial affiliates, as assigned.
· Ensure audits are thorough, compliance-driven, and aligned with corporate standards.
· Commercial Affiliates Support:
· Provide quality initiative support to commercial affiliates, ensuring alignment with regional and corporate standards.
Project and Task Execution:
· Lead quality programs and projects across the APAC and China regions, ensuring alignment with quality requirements and QA processes.
· Participate in program reviews, providing recommendations to ensure quality standards are met.
· Prioritize deliverables and manage project scope, ensuring effective end-to-end QA delivery across teams and sites.
· Regularly report project status to the QA Leadership team using relevant metrics, and track projects concerning resources, time to market, and budget constraints.
· Advise Senior Management on program status and risks, overseeing the decision-making process for project activities within manufacturing sites.
· Coordinate activities between site/project team members to ensure project requirements are met.
· Undertake additional tasks as assigned, contributing to the continuous improvement of quality systems and processes.
Requirements:
- Bachelor’s Degree or higher in Pharmaceutical and Life Sciences, Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.
- Preferably at least 5- 8 years of experience in QA, Operation or Technical Function in Pharmaceutical, Medical devices environment.
- Comprehensive understanding of quality systems and compliance regulations, including SOPs, GMPs, and quality standards (e.g., ISO, Auditing).
- Knowledge of worldwide GMP regulatory requirements and industry best practices.
- Manufacturing or Quality related experience in some of the following areas: sterile, liquid, solids or API’s.
- Ability to use Quality Risk Assessment and Root Cause Analysis tools
- Knowledge of inspection and auditing standards
- Ability to navigate and address cultural and language differences to provide effective solutions that meet corporate, regional, and local objectives.
- Familiarity with cultural practices and expectations within relevant regional markets is essential.
- Experience working in a multicultural environment is highly desirable.
- Proficient with Microsoft Office Suite (intermediate MS Excel knowledge required), Adobe Acrobat, Visio, MS Access. System experience using Trackwise, iQ, Isotrain, and general IT system data entry and report generation desired.
Interested applicants please send your resume to [email protected]
https://go.persolkelly.com/job/apply/7602
We regret that only short-listed candidates will be notified.
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