Senior Quality Control Analyst

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.

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. As a member of Site Investigation Team (SIT) needs to investigate quality events and perform Root Cause Analysis (RCA).

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.
• 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.
• Complete and maintain certified investigator training requirements to ensure SIT representation for identified area(s).
• Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPA’s.
• Participate in continuous improvement initiatives for investigations and associated investigation certification process.
• Work with CIT team as needed for Major and Critical Investigations to align with corporate guidelines.
• Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the Stability and Quality Control departments.
• Represent Glenmark as appropriate in FDA, notified body, internal and other regulatory audits.
• Work in close collaboration and support with other members of the CMC team responsible for drug product development and support to management, as necessary
• Domestic and international travel up to 5% may be required to accompany technical staff in the factory acceptance and inspection of laboratory equipment.
• Ensure training of QC Analyst (Entry level Positions)
• 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 :

A minimum of a Bachelor’s degree in Chemistry / Pharmaceutical Sciences or Equivalent.

Experience:

• 4+ 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 Analytical R&D.
Extensive knowledge in general laboratory equipment including but not limited to: GC, HPLC, Polarography, Particulate Matter, UV-Vis and FTIR

Knowledge and Skill:

• 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.
• Completed training on Six Sigma, certified Green belt professional.
• 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.