JOB DETAILS:

Key Responsibilities:

• • Carry out comparative dissolution studies for test products and reference comparator products to assure pharmaceutical equivalence
  • Carry out cleaning validation for new products that are developed at Formulation Development
  • Carry out analytical method validations and verifications and compile reports for the same to the Formulation Development to assure the consistency of the developed analytical method
  • Perform Analytical Method Transfer during transfer of the products from Formulation Development to Manufacturing
  • Carry out accelerated and long-term stability studies as well as compile reports of the same
  • Conduct impurity profiling of drug substances including the identification and quantification of impurities
  • Assist the Formulation Development Quality Chemical Officers in developing analytical methods, such as spectroscopy-based methods, chromatographic methods or dissolution methods amongst others
  • Assist the Formulation Development Officers in conducting experiments, analysing results and preparing reports for various pharmaceutical formulations developed
  • Execute and report experimental work related to biopharmaceutical characterization in support of drug product development
  • Participate in the evaluation of new analytical techniques in the area of pre-formulation sciences, automated workflows and biorelevant testing
  • Create and review specifications in the SAP system
  • Handle ERP System/ SAP for specification generations and Trackwise system for deviation and complaints
  • Prepare SOPs, FMECAs, protocols, and any other documents assigned by the line manager from time to time
  • Any other job responsibility/ assignment given by Supervisor/ Manager deemed fit within your jurisdiction

Qualifications and Experience Required 

• Bachelor’s Degree in Chemistry, Chemical Engineering, Industrial Chemistry, or Science Technology (Chemistry), or any other science related field
• Minimum of 3 years’ experience in Quality Control in a manufacturing plant or standard recognized laboratory
• Familiar with pharmaceutical regulations and guidelines, such as Good Manufacturing Practices (GMP) and International Council for Harmonization (ICH) guidelines
• Certification in Quality Management or Quality Assurance is an added advantage
• Good teamwork, interpersonal skills and adherence to Quality Management Systems
• Self-starter, flexible and able to work well under pressure at work
• Proficiency in Excel and its basic formulae, and in PowerPoint presentations
• Familiar with the various analytical tools like the Pareto Chart, Waterfall, Pie Charts, Bar Charts and Line Charts
• Be observant, creative and innovative in line with the business needs
• Able to work Shifts program as per business needs