Quality Control Analyst

Summary

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules. The Quality Control Analyst will perform QC analysis in compliance with cGMP standards, maintain data integrity, and ensure compliance during analytical testing in the QC lab.

Responsibilities

• Be cost effective and vigilant of laboratory reagents, glassware, etcetera to ensure department is within the Revenue and Capex Budget as per spent analysis project
• Provide feedback to management with laboratory standard hours for financial prudence in resource planning, allocation and manpower to ensure within approved budgets while building best in class quality processes and systems at site
• Execute and maintain quality system controls to ensure no critical and major market complaints
• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency
• Perform day to day activities for the chemical laboratory which shall include testing of in- process, RM, PM and FP samples, Swab sample and Tech Transfer (as applicable)
• Ensuring compliance to systems and procedures throughout product lifecycle
• Communicate with Supervisor and/or report any preparations or data that may result in an Incidence & OOS
• Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits
• Execute technology transfer of analytical methods for new products. Execute cleaning validation of new products
• Assist in the monitoring of changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab
• Apply CAPA for Lab failures in OOS
• Prepare in timely fashion updating and revision of SOP, specification, STP and any other documents
• Assist in timely completion of Tech Transfer of Finished products
• Ensure training of QC staff
• Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc
• Perform the Training Tracking Tool/Software for QUALITY Assurance and Quality Control

Skills

• B.Sc. in Chemistry with concentration in Biochemistry
• 1-3 years in the field of 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 in general laboratory equipment including but not limited to: HPLC, UV-Vis and FTIR
• Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system
• Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices
• Technical writing skills to generate SOPs and serve as the Subject Matter Expert
• Began training under Six Sigma and Project Management
• Support the Management to organize and maintain the QC team, good communications skills, front runner, and GMP trainer
• Will be an added advantage if the individual has dealt with multiple audits personally

Qualifications

Must Haves

• B.Sc. in Chemistry with concentration in Biochemistry
• 1-3 years in the field of 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 in general laboratory equipment including but not limited to: HPLC, UV-Vis and FTIR
• Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system
• Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices
• Technical writing skills to generate SOPs and serve as the Subject Matter Expert
• Began training under Six Sigma and Project Management
• Support the Management to organize and maintain the QC team, good communications skills, front runner, and GMP trainer

Nice to Haves

• Will be an added advantage if the individual has dealt with multiple audits personally