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Manager_Analytical Data Reviewer

8 - 13 years

10 - 15 Lacs

Mumbai

Posted:1 week ago| Platform: Naukri logo

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Skills Required

Analytical data review LIMS Method validation QC instruments as HPLC Electronic data review Method Transfer USFDA Dissolution Apparatus OOS QC instruments Quality Control investigations Lab Incidents OOT and Malvern 3000 Method Verification GC

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities :- Job overview :- The role requires strong analytical data review skills and experience with various QC instruments . The position involves supporting their North American sites , Potentially requiring the candidate to work according to US time zone. Key Responsibilities & Required Experience: Strong exposure to Analytical Data Review and electronic data review from QC instruments such as HPLC, GC, Dissolution Apparatus, and Malvern 3000 Thorough understanding of Quality Control investigations, including Lab Incidents, OOS, and OOT Preparation and Review of Method validation, Method Transfer, Method Verification and Equivalency documents, etc Review of Analytical raw data, Chromatography, and LIMS for Raw Materials/In-process/Finished Products. Preparation and Review of new SOPs. Candidates must have relevant experience in Oral Solid Dosage (OSD) formulations and/or Active Pharmaceutical Ingredient (API) processes. Kindly note the following: The selected candidate will support one of their sites in North America and will be required to work as per the US time zone . Strong communication skills are essential for this role.

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Talent Management

Los Angeles

50-100 Employees

112 Jobs

    Key People

  • Jane Doe

    Founder & CEO

  • John Smith

    Talent Agent

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