Specialist QA Operations (Career Conversion Programme Trainee)

Overview of Career Conversion Program (CCP)

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Program (CCP) for Biomedical Manufacturing Executives/Professional (Attach-And-Train) is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore's Biomedical manufacturing industry. This comprehensive 15-monthprogram features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligibility for CCP:

• Singapore Citizen or Permanent Resident, age 21 and above
• Mid-Career Individual: Have graduated and/or completed National Service for at least 2 years4 at the point of application OR
• Fresh Graduate: Have graduated and/or completed National Service for less than 2 years at the point of application
• Should not be shareholders, ex-employees of Novartis, or be related to shareholders of Novartis.

Job Summary

The Specialist - QA Operation 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.

Responsibilities

• Provide quality oversight to site operations including but not limited to the responsibilities below ensuring compliance with cGxP, incl. data integrity, regulatory and Novartis Quality Standards
• Perform QA review of production batch records including exception review and closure
• Lead / provide QA oversight of deviations including investigations, CAPAs, customer management etc
• Review and approval of other production GMP documentations (e.g. SOP,FRM, PCO, QTO etc)
• Provide support in ensuring inspection readiness. Support customer, internal Novartis and Health Authority audits
• Agile decision making, managing stakeholders and continuous improvement initiatives to achieve improved efficiencies in all areas under responsibility and establish of standard workflow processes
• Support OpEx improvement projects
• Comply with all HSE guidelines Detect and report potential accident, risks and propose solutions
• Any other task / duties assigned by line manager

Required competencies and certifications

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
• Eligibility to participate in the Career Conversion Program (CCP) as per program guidelines (e.g., new entrants to biopharmaceutical industry without existing bond obligations)

Preferred competencies and qualifications

• Good knowledge of GMP Continuous Learning Operational Excellence Digital &Tech Savvy

• Technological competence Quality Assurance Knowledge of GMP, Quality Standards Quality Control (QC) Testing