Glenmark Pharmaceuticals
Overview
Be among the first 25 applicants. Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCEs) and New Biological Entities (NBEs), with eight molecules in various stages of clinical development. The USA subsidiary also markets APIs to regulated and semi-regulated countries. This position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Responsibilities
Perform QC analysis in compliance with cGMP in line with USFDA standards. Maintain compliance to data integrity and cGMP in the QC lab in line with USFDA standards. Perform IOQ/Calibration for instruments in QC lab at Monroe with guidance from CQA. Execute and complete procedures and systems for RM, PM, FD and in-process testing in QC lab. Provide information and data for evaluation and execution of stability studies as per Quality and regulatory requirements. Timely complete testing and ensure compliance during analytical TT and AMV in the QC lab. Able to be a qualified trainer for QC related systems and SOPs and ensure personnel are appropriately trained. Education
B.Sc. in Chemistry with concentration in Biochemistry Experience
1-3 years in the pharmaceutical manufacturing facility. Background in the functional areas of Quality Control in Stability, Finished Goods and some Raw Materials with some experience in R&D. Extensive knowledge of general laboratory equipment including but not limited to: HPLC, UV-Vis and FTIR. Knowledge and Skills
Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory inspections, familiarity with QMS, Change control/deviations and market-compliant management systems. Skills in coordination of calibration and preventative maintenance services, including vendor contracts, processing quotes, purchasing orders and vendor invoices. Technical writing skills to generate SOPs and serve as the Subject Matter Expert. Training in Six Sigma and Project Management. Strong management support, good communications, GMP trainer, and ability to organize the QC team. Other Requirements (licenses, Certifications, Specialized Training)
Will be an added advantage if the individual has dealt with multiple audits personally.
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Be among the first 25 applicants. Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCEs) and New Biological Entities (NBEs), with eight molecules in various stages of clinical development. The USA subsidiary also markets APIs to regulated and semi-regulated countries. This position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Responsibilities
Perform QC analysis in compliance with cGMP in line with USFDA standards. Maintain compliance to data integrity and cGMP in the QC lab in line with USFDA standards. Perform IOQ/Calibration for instruments in QC lab at Monroe with guidance from CQA. Execute and complete procedures and systems for RM, PM, FD and in-process testing in QC lab. Provide information and data for evaluation and execution of stability studies as per Quality and regulatory requirements. Timely complete testing and ensure compliance during analytical TT and AMV in the QC lab. Able to be a qualified trainer for QC related systems and SOPs and ensure personnel are appropriately trained. Education
B.Sc. in Chemistry with concentration in Biochemistry Experience
1-3 years in the pharmaceutical manufacturing facility. Background in the functional areas of Quality Control in Stability, Finished Goods and some Raw Materials with some experience in R&D. Extensive knowledge of general laboratory equipment including but not limited to: HPLC, UV-Vis and FTIR. Knowledge and Skills
Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory inspections, familiarity with QMS, Change control/deviations and market-compliant management systems. Skills in coordination of calibration and preventative maintenance services, including vendor contracts, processing quotes, purchasing orders and vendor invoices. Technical writing skills to generate SOPs and serve as the Subject Matter Expert. Training in Six Sigma and Project Management. Strong management support, good communications, GMP trainer, and ability to organize the QC team. Other Requirements (licenses, Certifications, Specialized Training)
Will be an added advantage if the individual has dealt with multiple audits personally.
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