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Senior Executive - Quality Assurance - Biologics

3.00 to 6.00 Years   Chennai   06 Nov, 2020
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • This role involves in Analytical Quality Assurance activities pertaining to Quality Control Biologics (AQA activities of QC Biologics).
  • Review, approval of RM/PM/Consumable reports and release in SAP.
  • Coordination in preparation and review of the QA SOPs in-line with current pharmaceutical guidelines.
  • Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
  • Issuance of Analytical documents and document related Raw Materials/Packing Materials/Consumables.
  • Review of analytical test records, Analytical testing records, Analytical Method validation, Analytical method transfer, protocol and report as per written procedures
  • Review of stability summary and stability reports generated by QC as per written procedures.
  • Handling and being part of the investigations related to deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA and Out of trend.
  • Handling & management of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification.
  • Handling, review, evaluation of change control, verification and implementation of the Corrective and preventive action.
  • Review of specifications and STPs for RM/PM/IP/FP of QC Biologics.
  • Review of all laboratory analytical standard protocol, Reports & COAs.
  • Review of Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC.
  • To ensure implementation of all EHSS norms to create safe working environment.
  • Training of employees on various aspects like good documentation practices and Good Laboratory Practices.
  • 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 ScienceTechnical/functional Skills:
  • Should be good in Quality Control instrumentation.
  • Should have knowledge in Analytical testing records, Analytical Method validation, Analytical method transfer
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 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 be a focuses employee.
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Keyskills :
miscustomer relationsequal employment opportunitydeliverycustomer serviceanalytical method validationcontinuous improvement facilitationcommitment towards worksales

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