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Senior Executive QC Late Phase stability

3.00 to 6.00 Years   Delhi   17 Nov, 2021
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaMarketing / Communication
EmploymentTypeFull-time

Job Description

  • To review and handle change control, deviation, and CAPA with respect to Quality under GMP aspects and involve in the Document Management System.
  • Responsible for performing the physicochemical and instrumental analysis (HPLC, Dissolution, UPLC, GC, KF, pXRD, particle size, etc.) and investigations (Drug substance, Drug Product, Intermediate and Excipient)
  • Responsible for performing analytical method validation and analytical method transfer.
  • Deliver results Right First Time and within the established windows.
  • Participation in internal, client and regulatory audits.
  • Compliance with quality systems in laboratory.
  • Ensure and comply with GMP, GDP, Data Integrity EHS policies laid down by the organization.
  • Flexibility to work in any project/team as per the requirement.
  • Preparation of documents like stability summary reports, stability protocols, SOP.
  • Responsible for audit readiness.
  • Performance of instrument calibration, qualification whenever required.
  • Ensure and comply with EHSS and safety policies laid down by the organization.
Key Responsibilities:
  • First pass analysis of stability samples i.e. drug substances and drug products.
  • Ontime escalation of laboratory issues.
  • Initiation of QMS records on time.
Educational Qualification: M. Pharmacy or M.Sc. (Analytical Chemistry/Organic Chemistry)Technical/functional Skills:
  • 3 to 6 years of working experience in Stability or Quality control.
  • Candidate should have experience in analysis of drug substance and drug products.
  • Good analytical skill and shall perform analysis right first time.
  • Hand on experience of HPLC, GC, KF coulometer, KF titrator, Dissolution tester and IR. (experience in PXRD, DSC, Particle size analysis, LCMS is preferred.
  • Experience in Chromeleon software, LIMS, Trackwise will be added advantage.
  • Good understanding of GMP, GDP and data integrity principles.
  • Quick learner and early change adaptor.
  • Experience in regulatory audits is must.
Experience: 3-6 Years of working experience in Stability and Quality control. (Drug substances and drug products)Behavioral Skills:
  • Effective time Management.
  • Reading Comprehension
  • Communicating effectively: verbally and writing
  • Team player.
,

Keyskills :
missalescustomer relationscustomer servicedeliveryright first timeparticle size analysisanalytical method validationequal employment opportunity

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