Tuesday, August 31, 2021

Cipla Ltd is hiring for Team member - Scale up and Validation || Click here to read more


Company: Cipla Ltd

Job Location: Vikhroli


Education Qualification:

Master’s degree in industrial engineering/plastic engineering/instrumentation required

• Knowledge of primary regulatory requirements in pharma such as 21 CFR, ISO 13485 standards, IEC standards are preferable

• Knowledge of Polymers, injection molding and assembly automation must


Relevant Work Experience:

Experience at reputed of minimum 3 years in device development, automation for manufacturing/assembly and the medical devices is a must. 

• Experience in medical device manufacturing (direct operations/team handling) highly welcome 


Roles & Responsibilities:

I. Robustness protocol design, development, execution and reporting

  • Build test protocols, custom test rig concepts to test the performance and robustness of medical devices.
  • Conduct robustness studies with the device team and report the outcomes to regulatory and QA in the required manner 

II. Device design history file at Partner locations 

  • Work with regulatory and QA functions to complete device documentation such as functional specifications, component certifications, biocompatibility study, robustness study protocols
  • Recording of results and regulatory submission files

III. Scale-up assurance and quality checkpoint design at selected vendors for device manufacturing.

  • Conduct Failure mode and opportunity analysis, patient safety study.
  • Build designs of devices and electronics for scale-up which have the right quality checkpoints 

IV. Device performance and patient handling documentation 

  • Keep track of device-wise ergonomic and DMF iterations.
  • Build protocols for device similarity, patient handling study for regulatory submission

Click here to apply


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