Analytical Development – Analytical Validation

2+ years

Not Disclosed

Hyderabad

10 Sept. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Role: Analytical Validation
Department: Analytical Development
Location: Hyderabad

Job Description:

Ensure compliance with cGMP and Good Laboratory Practices (GLP).
Maintain general cleanliness and organization of the laboratory.
Collaborate with quality control personnel to monitor exhibit batch analyses.
Prepare instrument methods, method sets, and review sample processing methods generated in Empower software.
Oversee analytical method transfer, verification, and validation.
Conduct analysis of raw materials, finished products, and packaging materials.
Prepare and review protocols for method transfer, verification, and validation.
Prepare and review reports related to method transfer, verification, and validation activities.
Review and maintain reconciliation of electronic data generated in the quality control laboratory during method validation, verification, technology transfer, and feasibility studies.
Investigate any laboratory incidents occurring during method transfer, verification, and validation, and prepare incident reports.
Archive and retrieve analytical development documents from the QA department.
Ensure overall compliance with analytical documents and records generated in the quality control laboratory.
Provide relevant documentation for regulatory filings.
Participate in internal and external audits.
Procure columns, chemicals, reference standards, and impurity standards for analytical method activities.
Initiate change controls and manage deviations/incidents.
Review specifications and Standard Test Procedures (STPs).
Respond promptly to regulatory queries.
Undertake additional activities as required by the Head of Department, following their instructions and guidance.

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Analytical Development – Analytical Validation

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