Job Description

Summary Summary
This role support/provide 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 driven in alignment to site objective/s.Position Title: Senior QA Operations SpecialistLocation \xe2\x80\x93 SingaporeAbout the Role:
This role support/provide 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 objective/s.
Key Responsibilities:

• Ensure all activities in compliance with cGxP, incl. data integrity
• Review and approval of analytical data / tests (analytical release)
• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS & T records
• MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
• Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments. Preparation and participation to 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:

• 5+ 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\xe2\x80\x99s 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! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou\xe2\x80\x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsJoin 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 here: https://talentnetwork.novartis.com/network.Senior QA Operations SpecialistSkills Desired Continuous Learning, Gmp Procedures, Managing Ambiguity, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence

Novartis