Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
POSITION SUMMARY:
This position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in line with standards prescribed by USFDA. Maintain compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA. Perform IOQ/Calibration for instruments in QC lab at Monroe with guidance of CQA. Execute and complete procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical TT and AMV performed in QC lab. Able to be a qualified trainer for QC related systems and SOP’s and responsible that personnel are appropriately trained.
OVERALL JOB 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.
Education :
B.Sc. in Chemistry with concentration in Biochemistry
Experience:
- 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 a some experience in R&D.
Extensive knowledge in 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, 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.
Other requirements (licenses, certifications, specialized training)
Will be an added advantage if the individual has dealt with multiple audits personally.
