Chemist II

Job Description :

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Position Summary

As QC Chemist II, you will ensure that Quality control operations meet cGMP and Regulatory compliance and Data Integrity principals while respecting regulations, corporate standards and clients requirements.

This role is responsible for method transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical raw materials, intermediates and products. The role contributes to building and maintaining QC lab cGMP system, delivers analytical solution to clients through expertise in specific method qualification and validation strategies while ensuring timely delivery for projects.

Responsibilities

• To support new equipment qualification, lab computerized system and chemistry lab set up
• To perform transfer/verification/validation of laboratory procedures within the team where required
• To prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications and reports
• To perform analysis of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies
• To review analytical and laboratory data within the department for accuracy, completeness and compliance with documented procedures
• When the new pharmacopeia and regulations are updated, be responsible for identifying the gap of management process and operation process of chemistry laboratory and improve the compliance
• To perform write up for laboratory investigations, deviation and on time closure in line with Quality Management system procedures
• Management of QC chemical, reference standard and consumable stock levels
• To maintain own training records and support and train other team members as required
• To communicate effectively with others on site and internationally, and to participate with them in problem solving activities
• Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab
• Support and encourage a Quality Culture and company 4i values throughout QC
• Ensure cGMP is applied in their area of work and comply with cGMP in all areas of the business
• To work with HSE, cGMP and 5S in mind at all times
• Undertake ad-hoc activities that may be required by the business

Minimum Requirements/Qualifications

• Degree in Chemistry or strongly related scientific discipline
• At least 3 years relevant industrial experience
• Ability to apply GMP regulations and other international guidelines to all aspects of the position
• Ability to work independently and adhere to critical timelines
• Effective communication skills at all internal and external levels
• Excellent attention to detail