Aragen Life Sciences Jobs | Urgent Vacancy in Pharma Company

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Role: Senior Research Associate

(Location: Bangalore)

Experience: 3-7 years experience industry experience.

  • Primary responsibility is to review preclinical (In vivo & In vitro) reports of all clients and check their relevant compliance with client requirements, regulatory guidelines, and in-house standard operating procedures and generate audit reports for the same and also participate in the discussions in case of any client queries.
  • Primary responsibility is to do facility, system and process audits and review related documents both soft and hard copies and ensure their compliance with client and regulatory requirements.
  • Review Electronic Laboratory notebooks (eLNB) and ensure their compliance with regulations and ensure implementation of ALCOA+ principles.
  • To prepare and review protocols, and in-house standard operating procedures and maintain a schedule of revision dates and if any updates from global standard practices are to be included in a timely manner and uploaded into the electronic data management system (EDMS).
  • To review Liquid chromatography-mass spectrometry (LC-MS/MS) calibrations and validations and also check the audit trails of the specific studies.
  • Plan and conduct live audit/in-process, retrospective audit, safety audit & Laboratory audits.
  • Prepare template checklists for checking the reports and harmonize the report template format as per client requirements.
  • To manage the test compounds received from various clients.
  • To train the team about quality aspects and update about the regulatory guidelines, and client requirements.
  • Strong communication skills.
  • Capable of working independently and with a team.
  • Innovative and creative.
  • Capable of handling pressure & work with pace.
  • Enthusiastic to face new challenges.

Interested candidates with desired qualifications, please share your CV at [email protected]

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