Senior Executive, Analytical R&D

JOB PURPOSE

• Assist Analytical Assistant Manager to manage projects and maintains analytical laboratory by implementing Good Laboratory Practice (GLP) and adhering to MS ISO/IEC 17025 practice according to Duopharma Innovation Quality Manual to ensure high quality, safe and efficacious of Duopharma products.

KEY ACCOUNTABILITIES

• Develop and validate suitable, specific, precise, and accurate analytical methods for raw materials, active ingredients, intermediate, and finished products using any suitable equipment (i.e.: HPLC, GC, MS, ICP, AAS, etc.).
• Liaise closely with formulation section by having constant discussion to ensure continuous information flow, especially during project/ product development trial testing.
• Perform the stability study testing for the R&D batch.
• Prepare all the analytical-related documents, such as Laboratory (OneNote) Notebook, Analytical Development Report, Analytical Test Method and Specification, Raw Material Evaluation Report, Stability Study Report, SOPs, as well as documents for regulatory submission.
• Carry out and manage preventative maintenance and calibration of the equipment under responsibility by ensuring the equipment are calibrated and preventative maintenance is performed as per schedule.
• Assist the Quality Management, Production and Quality Control department during product scale up by providing product analyses information, solving problems and advising precaution steps to be taken during analysis.
• Assist new dossier product registration and support registration and query within agreed timeline.
• Assist in management of the lab by maintaining the equipment, inventory of lab operating supplies, chemical and ensuring general cleanliness and safety in the lab.
• Assist Analytical Assistant Manager in training new chemists / lab technicians by demonstrating the sample preparation and operation of analytical instruments, showing the steps to troubleshoot problems which occur during analysis.
• Strictly implement Good Laboratory Practice (GLP) and adhere to MS ISO/IEC 17025 system while working in the laboratory environment.
• Involve in ISO 17025 related activities.
• Supporting the administration of the analytical documents as Document Controller.
• Carry out other duties that may be assigned by management from time to time.

JOB REQUIREMENT

• Bachelor or Master of Biochemistry and any other related field of studies.
• 6 years experiences in pharmaceutical/ related industry with good work records and extensive experience in similar capacity. Specialized skills/Knowledge for the role
• Method development and method troubleshooting
• Dossier preparation for product registration Technical Competencies
• Extensive knowledge in laboratory analysis
• Familiar with the pharmaceutical requirements
• Familiar with new product registration requirement
• Strong research abilities and persistence.
• Able to operate analytical instruments: FT-IR, UV-visible, GC, HPLC-UV, HPLC-PDA, AAS, Dissolution, Auto-Titration, Karl Fisher, UV-VIS, ICP-OES and Disintegration.
• Familiar with the requirements of National Pharmaceutical Control Bureau (NPCB), Food and Drug Authorities (FDA), ICH guidelines, ASEAN guidelines, EMEA guidelines, good laboratory practice (GLP) and WHO.
• Proficient in Microsoft Office (Words, Excel and Presentation) Behavioral Competencies
• Strong ability to communicate effectively at all levels of employees, excellent presentation skills.
• Exercise integrity in all situations and champions the CCM Core Values.
• Ability to strategize and execute in a timely manner without compromising on quality of deliverable.
• Having the maturity, wisdom and ability to exercise fair judgment in decision making.
• Good leadership skills, ability to take control, charismatic, displays positive aura and ability to inspire and motivate employees.
• Capable to adapt with the changes and willing to learn new things.