Qa operations specialist

2 weeks ago

Singapore Healthcare Businesswomen’s Association Full time

Job Description Summary This role supports/provides quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full GMP compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objectives. Job Description Position Title: QA Operations Specialist Location: Singapore About the Role: This role supports/provides quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full GMP compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objectives. Key Responsibilities: Ensure all activities are in compliance with c Gx P, including data integrity. Review and approval of analytical data/tests (analytical release). Oversight of all production and testing activities, ensuring compliance with c Gx P, including data integrity and e Compliance. Support exception investigations. Review and approval of production, QC, and AS&T records. MBR review. Support Op Ex improvement projects. Execute batch release in compliance with registration (if Qualified Person). Comply with all HSE guidelines. Detect and report potential accidents, risks, and propose solutions. Participate in HSE risk assessments. Preparation and participation in internal HSE audits. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements: Essential Requirements: 3+ years of experience in pharmaceutical quality control, quality assurance, or production. Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice. Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy. MS Office applications and other standard IT applications supporting Quality activities. Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing. Desirable Requirements: University degree with a scientific/technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent). Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Benefits: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network. Skills Desired: Continued Learning, Dealing With Ambiguity, GMP Procedures, QA (Quality Assurance), Quality Control (QC) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence. #J-18808-Ljbffr

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