QC Senior Biochemist

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - 8 Tuas Bay Lane Singapore

Job Purpose
Support establishing and maintaining a Bioanalytical lab in Novartis BioProduction Operations Singapore QC following Novartis cGMP standards. Provide technical support for the laboratory, and ensure testing in accordance with local and international regulations. Participate to analytical transfer evaluation and execution for his/her unit.

Key Responsibilities
  • Establish and maintain QC Bioanalytical lab in full cGMP-compliance
  • Support lab equipment installation and qualify/validate lab equipment for intended use in QC laboratory
  • Preparation and support in developing of equipment validation protocols and reports
  • Responsible/ provide technical support to run and validate necessary test methods on lab equipment and later perform product testing under cGMP
  • Maintain product reference and assay control programs
  • Develop/Trains QA/QC associates on new methods and instrumentation
  • Responsible that laboratory is operating following Novartis cGMP standards
  • Ensures that priorities for testing and review are set and followed
  • Participate and check workload scheduling and prioritization of staff to ensure documents are reviewed and testing is performed in a timely manner
  • Monitoring and optimization of work flows and methods/procedures, in-process control, DS and stability, method controls and reference's and perform trending of on-going in process control data to pursue an on-going quality assurance program
  • Lead laboratory investigations and facilitates root cause finding
  • Reviews/Approve QA/QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs
  • Optimizes test procedures to improve efficiency whenever possible
  • Prepare and participate to health authorities inspections and internal
Requirements
  • Masters or Degree in Pharmacy, Biotechnology, Microbiology or Chemistry with minimum 6 years of experience in GMP-regulated industries in Quality Control
  • Must understand FDA and ex-USA regulatory requirements as well as industry quality systems
  • Must have an understanding of pharmaceutical industry trends and practices
  • Experience is required with knowledge and understanding of quality control in manufacturing
  • Must have good interpersonal skills, ability to work under pressure and flexible


Post Date 05 December 2017
End Date 04 January 2018

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Company Profile

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Singapore - West - Tuas

Novartis BioProduction Operations Singapore is a new entrant to the Singapore biologics sector. Our facility will focus on drug substance manufacturing based on cell culture technology. The site is designed to handle small and large scale volumes to support both clinical and commercial production of potential new products.