Quality Assurance Trainee

3 weeks ago

Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

Position Overview

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

Successful participants 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, notifications of supplier changes, and the management of new materials. To ensure Quality oversight in logistics management and warehouse operations. Key Duties:
Supplier Oversight Deliver Quality Assurance oversight of supplier management activities on-site to ensure compliance with company policies and regulatory requirements. Participate and represent the site in Supplier Management processes to drive enhancements and share best practices across the network. Act as the process owner for supplier complaint management related to incoming materials, ensuring suppliers identify root causes and implement corrective actions to prevent recurrence of quality issues. 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 promptly and escalate as necessary, particularly in cases affecting supply. Initiate and review deviations/change controls/corrective actions associated with incoming materials. Collaborate closely with site users and global stakeholders on supplier management matters. Quality Assurance for Raw Materials and Warehouse Management Assist in the review and release of incoming material documentation to confirm the Usage Decision (UD) of raw materials. Ensure completeness and accuracy of material documentation files before material disposition in the system. Establish a system for filing and archiving material documentation files. Initiate and review deviations/change controls/corrective actions related to incoming material releases. Ensure all deviations/change controls are resolved or assessed for impact prior to the release of QA-controlled incoming materials. Provide Quality Assurance oversight for warehouse operations, 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, maintaining awareness of business requirements. Conduct investigations and assessments of deviations. For QA Executive roles, provide oversight on routine situations independently and complex situations with supervision. Manage simple departmental projects with supervision, demonstrating greater awareness of business needs and escalation considerations. Required Skills: Professional A minimum of a basic university degree in a Science or Engineering discipline.
Technical Strong understanding of cGMP regulatory and legal standards applicable to pharmaceutical quality assurance. Familiarity with SAP is preferred. Ability to manage and organize multiple workflows effectively.
Business Capability to facilitate business activities aligned with international regulatory standards. Proficient 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. Commitment to professional and ethical integrity. Proficiency in the English language. Demonstrates a sense of urgency. Ability to work independently and collaboratively as part of a team. Location: This position will be based at one of our manufacturing sites in Singapore. About Us: GSK is a global biopharmaceutical company dedicated to advancing science, technology, and talent to combat disease collectively, positively impacting the health of billions and ensuring sustainable returns for shareholders. Our mission includes preventing diseases and treating them, aiming to enhance the health of 2.5 billion individuals by the end of the decade.

Our success is intrinsically linked to our people. We strive to create an environment where individuals feel inspired, valued, and included, enabling continuous growth and well-being. If you share our vision, we invite you to explore this opportunity with us. Important Notice: GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site. All employment businesses/agencies must contact GSK's commercial and human resources department for prior written authorization before referring candidates.

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