Deputy Manager/Manager-Analytical Method Validations(Formulations)

Aizant

11 - 13 years

0 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

analytical method validation analytical validation protocol gc troubleshooting method development hplc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dear All,

Analytical Method Validation activities

Experience: 11-13 Years

Location: Hyderabad(Dulapally)

Key Responsibilities:

Plan, design, and execute
Analytical Method Validation (AMV)
and
Analytical Method Transfer (AMT)
activities for formulations as per regulatory guidelines (ICH, USP, EP, WHO, etc.).
Review and approve
Validation Protocols, Reports, Method Development Reports, and Specifications.
Ensure
method robustness, accuracy, precision, linearity, and stability
are established and documented.
Lead
instrumental analysis using HPLC, GC, Dissolution, UV, and other analytical techniques.
Review and interpret analytical data generated during method validation and transfers.
Handle
regulatory audits (USFDA, MHRA, WHO, EU, etc.)
and ensure compliance with cGMP, GLP, and data integrity standards.
Coordinate with
Formulation Development, Quality Assurance, and Production
teams for analytical support.
Mentor and guide junior analysts/scientists in method validation and troubleshooting.
Support in
OOS / OOT investigations, change controls, deviations,
and other quality notifications.
Participate in
documentation and review of SOPs, STPs, GTPs, and validation master plans.
Strong knowledge of
regulatory requirements (ICH Q2R2, USP, EP, FDA, MHRA, WHO)
.

raghuveera.vutla@aizant.com

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