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 designed to cultivate the next generation of proficient talent for Singapore's Biopharmaceuticals manufacturing sector, anticipating future hiring needs.

Successful trainees will receive a certificate upon completing the programme.

Objective: To oversee interactions with external organizations supplying Quality Assurance (QA) for incoming materials and/or services. To manage the release of materials, supplier change notifications, and new material oversight. To ensure Quality oversight in logistics and warehouse operations. Key Duties:
Supplier Oversight Provide QA supervision of supplier management activities on-site to ensure compliance with company policies and regulatory standards. Participate in and represent the site for Supplier Management processes to enhance operations and share best practices across the network. Act as the process owner for supplier complaint management related to QA incoming materials, ensuring root cause analysis and corrective actions are implemented. Monitor and track supplier-related corrective actions for timely resolution. Maintain readiness for inspections and conduct assessments of both new and existing service providers promptly. Keep the approved supplier list and audit schedule compliant and accurate. Evaluate supplier change notifications swiftly and escalate issues when necessary, particularly those 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 for Raw Material Release and Warehouse Oversight Assist in reviewing documentation for incoming materials and recommend usage decisions. Ensure completeness and accuracy of material documentation before material disposition in the system. Establish a systematic approach for filing and archiving documentation. Initiate and review deviations/change controls/corrective actions related to material releases. Confirm that all deviations/change controls are resolved or assessed for impact prior to releasing QA-controlled incoming materials. Provide QA oversight in warehouse operations, including participation in warehouse meetings, conducting inspections, and managing related deviations, corrective actions, and change controls. Decision-Making:
Proposals & Recommendations Suggest enhancements to work processes, maintaining awareness of business requirements. Conduct investigations and assessments of deviations. For QA roles with additional responsibilities: Provide QA oversight on routine matters independently and complex situations with guidance. Manage straightforward departmental projects with supervision. Demonstrate a deeper understanding of business requirements and identify areas needing escalation. Required Skills: Professional A minimum of a university degree in a Science or Engineering field.
Technical A solid understanding of cGMP regulations and legal requirements relevant to pharmaceutical quality assurance. Familiarity with SAP is preferred. Proficient in managing and organizing multiple workflows.
Business Capable of facilitating business operations in line with international regulatory standards. Effective communication skills within the organization and across the network. Competencies: Knowledge of FDA/EU/ICH/WHO and other relevant regulatory and technical guidelines. Analytical mindset with a focus on quality performance. Uphold professional and ethical integrity. Proficient in English. Demonstrate a sense of urgency. Ability to work independently and collaboratively as part of a team. Location: The position will be based at one of our manufacturing sites in Singapore. Why Choose Us? GSK is a global biopharmaceutical company dedicated to advancing science, technology, and talent to combat disease collectively, positively impacting the health of billions while ensuring sustainable returns for shareholders. Our success is rooted in our people, and we strive to create an environment where individuals feel inspired, valued, and included, allowing them to grow and prioritize their well-being. If you share our vision, we welcome you to explore this opportunity with us.

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