Quality Assurance - DMPK, Toxicology, Biology ( Immediate Joiners)

SAI Life Sciences

6 - 11 years

4 - 8 Lacs

hyderabad

Posted:3 weeks ago| Platform:

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Skills Required

toxicology dmpk pharmacology pharmacokinetics quality assurance biology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Handle QA responsibilities for DMPK, Toxicology and Biology departments.
Handle Document Control and archiving activities.
Preparation of SOPs and forms.
Review of departmental SOPs, forms and documents for completeness and clarity.
Handling DMS
Review or inspection of study specific raw data and reports for toxicology, PK, Toxicokinetic and pharmacology studies.
Review of Study Plans (Protocols) for Toxicology and invivo Biology studies.
Conduct of the in life phase inspection
Scheduling and planning for study, facility and process based inspections and performs inspection.
Review of Laboratory Note Books.
Preparation and sharing of inspection reports
Issuance of forms, Logbooks and Laboratory note books.
Verification of GDPs, Data integrity.
Conduct Facility Inspections
Maintenance of documentation required for AAALAC audit.
Overview of archives document and specimen for Indexing, Archival, retrieval and Disposal of archived

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