Senior Executive

3 weeks ago

Thiruvananthapuram, Kerala, India Terumo BCT Full time

Job Band Job Band 13 JB13 Hiring Manager Akhil Kodiyamtharappel Sadasivan Lead Recruiter Tino Manimuthu Country IndiaOur ability to grow develop new capabilities and serve even more patients around the world depends on associates like you who are passionate about our mission Thank you for considering this new opportunity to further unlock your potential JOB SUMMARY -Ontime completion of testing analysis and documentation with respect to regulatory guidelines REPORTING -Reports to Deputy Manager QCESSENTIAL DUTIES -Administration Internal Communications Responsible for completing testing as part of Chemical Functional and incoming inspection Responsible for Document Review and Approval Responsible for providing support to Global Quality projects Responsible for providing support to complete gap assessments Other duties and responsibilities Responsible for Analysis and inspection of raw materials accessory items and finished product Responsible for Document and Test Report Reviews and Approval Responsible for In-process Testing and water testing Responsible for making sure that data is accurately recorded in accordance with guidelines Responsible for reporting trending and presenting results Responsible for Calibration of Glassware and Instruments Responsible for ensuring products are complying to the established regulatory guidelines with respect to product compliance Responsible for ensuring GLP and cGDP requirements are in place Responsible for supporting WCM Lean Six Sigma projects root cause analysis Productivity projects Responsible for empowering people by giving required training Responsible for qualification of analytical instruments and QC equipement Responsible for New product evaluation and stability studies Responsible for Monthly trending of test results Responsible for subcontractor training and audits MINIMUM QUALIFICATION REQUIREMENTS -Education Master s degree in chemistry or Bachelor s Degree in Pharmacy or Master s Degree in Pharmacy Pharmaceutical Analysis Pharmaceutics Pharmaceutical Chemistry Experience 7 to 10 years of experience in Testing laboratory of pharmaceutical industry Technical Experience knowledge and Skills required in below Knowledge on instrumental analysis Ion chromatography HPLC UV GC FTIR etc Knowledge on performing test as per Pharmacopoeial requirements USP IP EP Data Integrity Knowledge on different type of chemical analysis Able to understand and identify key objectives across the business Able to deal with multiple issues tasks and priorities concurrently Knowledge about Analytical Microbiological test and Equipment Qualification Preferable to have Knowledge about USFDA EuGMP requirements Need to work in all 3 shifts including night shift on requirement Additional Requirements Capable to work in all shifts including All three shifts Night Shift on requirement Have strong communication skills complimented with right technical skills to drive meaningful discussions

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