Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
Post : Executive - Analytical
Department : Analytical - Baxter Global Research Center (BGRC
Job Description :
Job Purpose:
This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, etc.
Key Responsibilities :
• Ensure proper planning and executions of laboratory analysis, method development, method validation, method transfer work within window and avoiding any human errors.
• Ensure that the data generated is accurate, scientifically valid and compliant to the procedures and maintain the lab work as per Current Good Manufacturing Practice standards (cGMP) standards.
• To ensure immediate escalation of issue not in conformity with the applicable procedures/policies etc.
• Responsible for closure of apparent error, incident, deviations, Out of Specification (OOS), Out of Trend (OOT), and Out of Calibration (OOC) related investigation if any observed during the individual involved analysis. Ensuring that they are handled and closed in scientific, logical, and compliant way in timely manner. Appropriate Root cause defined, Corrective and Preventive Actions (CAPA) identified and executed. Change Control Form (CCF) evaluated executed and closed in timely manner. Extensions if required taken in timely manner. Complete ownership of initiated quality record.
• After identification, quality record (apparent error, incident, deviation, OOC) need to be opened within 24 hours, assessment and write-up need to be submitted through tracker within 7 days or at an earliest per the issue in hand.
• In case of OOS, OOT regulatory timelines need to be followed.
• Competency matrix score need to be improved and two new techniques need to learned and qualified.
• Ensuring compliances to EHS policies, cGMP policies, data integrity policies, business policies, finance policies and IT policies as per requirements.
• Adherence to Good Laboratory Practice.
• Responsible for Maintenance and Calibration of assigned Measuring and Testing Equipment / Instrument in Quality Control (QC) in coordination with Maintenance department
• Attend mandatory trainings as and when conducted.
• Ensure trusting, collaborative and ethical work environment.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company
Candidate Profile :
• M.Sc or M.Pharm
• Requires good experience in analyzing sample using HPLC, GC, UV Spectrophotometer, Polarimeter, KF, auto titrator
• Should have 2-3 years of experience in Method validation/ Method development
• Experience on handling Empower-3 Software and LCMS or GCMS will be added advantage
• Good communication and e-mail writing skills
• Fair interpersonal skills.
• Good Team player
• Able to work follow instructions and perform the tasks under the supervision of the Team leader
Additional Information
Experience : 2-3 years
Qualification : M.Pharm or M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2022
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