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Tech. Associate - GT&E

1.00 to 3.00 Years   Chennai   13 Apr, 2021
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaService / Installation / Repair
EmploymentTypeFull-time

Job Description

  • Theoretical & practical knowledge on working principle of analytical instruments- FTIR, UV, IR, HPLC, GC with minimum 1 years of relevant experience
  • Understanding on the purpose of different method validation parameters and ICH guideline requirements.
  • Theoretical knowledge on titration, LOD and understanding the working principle of DSC and TGA etc.,
  • To be able to perform the compilation of methods and its requirements.
  • Ensure compliance to cGMP/ cGLP, organizations procedures and practices.
  • Ensure effective safety systems are implemented in the premises.
  • Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
  • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Identifying and implementing potential process improvements in conjunction with manufacturing operations.
  • Participating in start-up efforts of new equipment, software or processes in manufacturing.
  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
  • Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
Technical Skills:
  • Experience in Analytical Development/ validation / Technology Transfer of Injectable formulations to cater regulated markets, essentially experience in Plant Technology Transfer support in Injections including process validation.
,

Keyskills :
equal employment opportunitycontinuous improvement facilitationproduct qualitymethod validationtechnology transferstatements of work sow

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