Quality Assurance Trainee

3 weeks ago

Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

Overview

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development initiative designed to cultivate the next generation of skilled workforce for Singapore's Biopharmaceuticals manufacturing sector in anticipation of future hiring needs.

Successful trainees will receive a certificate upon completion of the programme.

Objective: To oversee interactions with external organizations that provide Quality Assurance for incoming materials and/or services. To manage the release of materials, supplier change notifications, and new material management processes. To ensure Quality oversight in logistics management and warehouse operations. Key Duties:
Supplier Management Provide Quality Assurance oversight of supplier management activities on-site to ensure compliance with corporate policies and regulatory requirements. Actively participate and represent the site in Supplier Management business processes to drive enhancements and share best practices across the network. Serve as the process owner for supplier complaint management regarding incoming materials. Document supplier complaints and ensure that suppliers identify root causes and implement corrective actions to prevent recurrence of quality issues. Review and monitor supplier-related corrective actions for timely resolution. Maintain inspection readiness and conduct assessments for both new and existing service providers promptly. Keep the approved supplier list and audit schedule compliant and accurate. Assess supplier change notifications promptly and escalate when necessary, particularly in cases affecting supply. Initiate and review deviations/change controls/corrective actions related to incoming materials. Collaborate closely with site users and global stakeholders on supplier management matters. QA Raw Material Release and Warehouse Oversight Assist in the review and release of incoming material documentation to recommend and confirm the Usage Decision (UD) of raw materials. Ensure that the material document file (MDF) is complete and accurate before material disposition in the system. Establish a system for filing and archiving of MDF. Initiate and review deviations/change controls/corrective actions associated with incoming material releases. Ensure all deviations/change controls are resolved or assessed for impact on material release prior to the release of QA-controlled incoming materials. Provide Quality Assurance oversight in the warehouse, including participation in warehouse tiers, conducting inspections, and managing warehouse-related deviations, corrective actions, and change controls. Decision-Making:
Proposals & Recommendations Suggest improvements to work processes, with a basic understanding of business requirements. Conduct investigations and assessments of deviations. For QA Executive 2: Capable of providing Quality Assurance oversight on routine situations independently and complex situations with supervision. Able to manage simple departmental projects (e.g., continuous improvement) with supervision. Increased awareness of business requirements and the ability to highlight considerations for escalation. Required Skills: Professional A minimum of a university degree in a Science or Engineering discipline.
Technical A solid understanding of cGMP regulatory and legal requirements as they apply to quality assurance in pharmaceuticals manufacturing. Experience with SAP is preferred. Ability to manage and organize multiple workflows effectively.
Business Capability to facilitate business activities in alignment with international regulatory standards. Proficient communication skills within the organization and across the network. Competencies: Familiarity with FDA/EU/ICH/WHO and other relevant regulatory and technical guidelines. Possess an analytical mindset focused on quality performance. Exhibit professional and ethical integrity. Proficient in the English language. Demonstrate a sense of urgency. Ability to work both independently and collaboratively as part of a team. Location: This position will be based at one of our manufacturing sites in Singapore. Application Process: GSK is a global biopharmaceutical company dedicated to uniting science, technology, and talent to advance healthcare and positively impact the health of billions of people. We are committed to creating an environment where individuals can thrive, feel valued, and continue to grow professionally. If you share our ambition, we invite you to explore this opportunity with us.

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