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Executive / Analyst QC

3.00 to 6.00 Years   Bangalore, Chennai, Hyderabad, Kolkata   04 Jan, 2022
Sygene
Job LocationBangalore, Chennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaStatistics / Analytics
EmploymentTypeFull-time

Job Description

Designation: ExecutiveJob Location: BangaloreDepartment: Quality ControlAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Performing analysis RM, PM, Intermediates, API and Formulation Finished products.Key Responsibilities:

  • Instrument qualifications and computer system validation (CSV) as per 21 CFR part 11 and GAMP 5 requirement.
  • Handling of instrument calibration, preventive maintenance and instrument management activities.
  • To log change control and prepare documents related to instrument qualification.
  • Risk assessment and SOP/ IOP preparations for new instrument installations or upgradations.
  • Experience in LIMS, ELN, SAP, Chromeleon, Trackwise application softwares.
  • Responsible for audit trail reviews and date & time verification of laboratory instrument softwares.
  • Responsible for troubleshooting software issues in laboratory instruments and creation of reporting templates in instrument softwares.
  • Following Good Laboratory Practices while working in QC Laboratory.
  • Carryout the analysis of samples as per the method of analysis/ Specification/ protocol.
  • Initiation of laboratory incident and deviation.
  • Preparation of calculation sheets and making draft reports.
  • Analysis of Intermediate, finished product and Working standard qualification as per the specification.
  • Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
  • Preparation of protocols and Observation data sheets.
  • Should be well versed with latest analytical technique like HPLC/GC, KF/KFC, IR/UV, etc.
  • Well-versed with Chromeleon data management application and LIMS will be an added advantage.
  • Operational Knowledge and troubleshooting of LC-MS, GC-MS, IC, and ICP-OES/ICP-MS will be added advantage.
Educational Qualification: M.Sc. / M. Pharma (Analytical/General Chemistry)Technical/Functional Skills:
  • Should be well versed with the latest analytical technique like HPLC, GC, FTIR, UV, Polarimeter, Refractometer, Densitymeter, KF/Auto Titrator, Coulometry and Conventional Methods.etc.
  • Well-versed with Chromeleon data management application and Labware LIMS will be an added advantage.
  • Familiar with Chromatography and Non-Chromatography Analysis of Drug Substances and Drug Product.
Experience: 3 - 6 yearsBehavioral Skills:
  • Strong commitment towards work and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
  • Good speaking-listening-writing skills, attention to detail, proactive self-starter.
  • Ability to work successfully in a dynamic, ambiguous environment.
  • Ability to meet tight deadlines and prioritize workloads.
  • Ability to develop new ideas and creative solutions.
  • Should able to work in team and flexible for working in shifts.
  • Should be a focused employee.
Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, and expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
21 cfrcomputer system validationequal employment opportunitycontinuous improvement facilitationaudit trailanimal healthcommitment towards workchange controldata managementconsumer goods

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