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Junior Manager Quality Control-Biologics

10.00 to 12.00 Years   Delhi   28 Jun, 2021
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • Daily laboratory monitoring, responsible to perform, record and review the daily / monthly verification, calibration of equipment and instruments.
  • Responsible to involve in the QMS investigation and providing the recommendation during the investigation in consultation with section head/group leader.
  • Review of documents pertaining to Method validations, batch release, instrument/equipment qualification, Calibration and Computer System Validation.
  • Closure of laboratory incidents related to Analytical team.
  • Review of specification/method of analysis/ODS in LIMS and EDMS.
  • Preparation and review of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc
  • Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.
  • Responsible to troubleshoot the problems, provide technical guidance, and mentor junior staff.
  • Responsible for the preparation and review of Stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets.
  • Responsible to initiate and inform immediately to department HOD/designee, if there are any laboratory incidents, deviations, change controls and out of specification results were observed.
  • Review of all the compliance documents on monthly basis for the Equipment and instruments documents like calibration records/reports, logbooks related to Analytical and Biochemical sections.
  • Participating in internal/external audits and inventory management in LIMS (Reference standard, Column and Chemicals)
  • 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.
Educational Qualification: Masters in scienceExperience: 6 10 yearsTechnical Skills:
  • Technically sound in analytical methods like (HPLC, UPLC, UV spectrophotometer, pH meter, Weighing balance, PCR, CGE and iCE).
  • Preparation of documentation such as SOPs, IOPs, EOPs etc.
  • Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols, validation protocols and reports etc.
  • Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product.
Behavioral 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 details, 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.
,

Keyskills :
quality controlcalibrationisoinspectioncommitment towards workequal employment opportunitycontinuous improvement facilitationph meter

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