Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.
The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.
- The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.
- Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations.
- Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.
- Participates in troubleshooting analyses and instrumentation. Trains less senior staff.
- Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
- Uses laboratory software for analyses.
- Reviews and approves laboratory test data and documentation for completeness and compliance.
- Is alert to and detects abnormalities during performances of tests and reviews.
- Elevates abnormalities to Supervisor
- Performs lab methods transfer and participate in method validation/verification studies
- Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
- Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.
- Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs.
- Detects, conducts and reports on OOS/OOT/NOE and other investigations.
- Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action.
- Writes, edits and reviews SOPs and laboratory investigations.
- Maintains assigned training records current and in-compliance.
- Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures
- Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.
- Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.
- Follows internal processes related to controlled substances.
- Follows EH&S procedures to ensure a safe work environment.
- Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.
Education & Experience:
- Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR,
- Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience.
- Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
- Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
- Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
- Has demonstrated competence in conducting chemical analyses
- Strong knowledge of wet chemistry techniques
Competency in Microsoft Office Suite
Skills & Abilities:
- Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management.
- Ability to display and analyze data in a logical manner.
- Strong verbal and written communication skills as well as good computer skills.
- Strong attention to details and accurate record keeping.
- Establish and maintain cooperative working relationships with others.
- Solid organizational skills.
- Ability to coach less senior staff and develop laboratory skills and ability.
- Ability to take initiative, set priorities and follow through on assignments.
- Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
- Must occasionally lift and/or move up to 15-25 lbs.
- Ability to wear personal protective equipment, including respirators, gloves, etc.
- Specific visions abilities are required by this job include close vision and color vision
- Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods