Piramal Enterprises
Business: Pharma Solutions
Department: Analytical Quality Control (AQC)
Location: Lexington
Reporting Structure This position reports to the AQC Group Lead.
Job Overview Reporting to the AQC Group Lead, the Chemist I performs testing of raw materials, in-process and finished products, and maintains and calibrates analytical instruments in compliance with cGMP standards.
Key Responsibilities
Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc. with minimum supervision
Testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
Document laboratory work according to, GDP, cGMPs, and SOPs
Troubleshoot, calibrate and maintain instruments as required
Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
Participate in laboratory investigations
Perform peer review of analytical documentation
Follow safety procedures when working in laboratory.
Understand and comply with cGMPs and other regulations
Maintain the laboratory in an organized and neat manner
Act as backup for Material sampling activities.
Purchasing of laboratory reagents and consumables
Qualifications
Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
Minimum 1-year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis strongly preferred
Experience working with potent, cytotoxic materials and parenteral drug products preferred
High level of proficiency operating all Microsoft Office applications
Excellent communication skills, both verbally and in writing
Detail oriented and organized
Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility
Excellent problem solving, communication, and interpersonal skills
Ability to follow written instructions
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Reporting Structure This position reports to the AQC Group Lead.
Job Overview Reporting to the AQC Group Lead, the Chemist I performs testing of raw materials, in-process and finished products, and maintains and calibrates analytical instruments in compliance with cGMP standards.
Key Responsibilities
Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc. with minimum supervision
Testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
Document laboratory work according to, GDP, cGMPs, and SOPs
Troubleshoot, calibrate and maintain instruments as required
Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
Participate in laboratory investigations
Perform peer review of analytical documentation
Follow safety procedures when working in laboratory.
Understand and comply with cGMPs and other regulations
Maintain the laboratory in an organized and neat manner
Act as backup for Material sampling activities.
Purchasing of laboratory reagents and consumables
Qualifications
Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
Minimum 1-year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis strongly preferred
Experience working with potent, cytotoxic materials and parenteral drug products preferred
High level of proficiency operating all Microsoft Office applications
Excellent communication skills, both verbally and in writing
Detail oriented and organized
Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility
Excellent problem solving, communication, and interpersonal skills
Ability to follow written instructions
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