QC Chemist, Raw Material - Novartis - Singapore

Job description

Job Description

The QC Chemist, Raw Material will report to the QC Lead at Novartis BioProduction Operations Singapore.

Job Purpose

Support all activities establishing and maintaining a Quality Control (QC) Raw Materials release lab in BioProduction Operations QC. All testing and sampling of incoming raw materials and consumables, to support production needs and document in accordance with written testing SOP’s and in accordance with local/international regulations.

Key Responsibilities

• Establish and maintain QC Raw Materials laboratory in full cGMP-compliance
• Assist in the installation of laboratory equipment and qualification of laboratory equipment for intended use in QC laboratory
• Preparation and reviewing of equipment qualification protocols and reports
• Participate in the validation and transfer of internal test methods, as well as method verification of compendial methods
• Perform raw material and consumables sampling in accordance to written testing SOP’s and in accordance with local/ international regulations
• Perform raw material testing following United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS) and/or Internal Validated Methods
• Ensure raw materials have been manufactured, tested or inspected according to specifications and current testing
• Support in establishing and controlling of raw material’s supplier qualification program
• Monitoring and optimization of work flows and methods/procedures, in-process control, method controls and reference’s and performs trending of on-going in process control data to pursue an on-going quality assurance program
• Participate in laboratory investigations as per local SOP and facilitate root cause analysis.
• Review QC documents to ensure completeness, accuracy, consistency, and clarity and raw materials have been manufactured, tested, or inspected according to specification, local SOP and cGMPs
• Assist in optimizing test procedures to improve efficiency whenever possible
• Prepare and participate to health authority’s inspections and internal audits in QC Raw Material area

Desired profile

Minimum requirements

• Masters or Degree in Pharmacy, Biotechnology or Chemistry
• Minimum 2 years’ experience in pharmaceutical GMP-regulated industries in Quality Control Raw Materials lab or equivalent experience
• Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standards, and industry quality systems
• Experience in performing analysis of USP and EP pharmacopeia methods
• Strong interpersonal skills, able to work in a team
• Ability to work under pressure, assert oneself and have high flexibility