Executive-Analytical Method Validations(Formulations)

Aizant

5 - 7 years

0 Lacs

hyderabad

Posted:-1 days ago| Platform:

Apply

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: 5-7 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

More Jobs at Aizant

Executive/Senior Executive-Analytical Documentation

Hyderabad

2.0 - 4.0 yrs

INR 0 - 1 Lacs

Walkin-Interview For QA & QC(Formulations)

Hyderabad

2.0 - 7.0 yrs

INR 0 - 0 Lacs

Stores Executive (Clinical Exposure)

Hyderabad

1.0 - 2.0 yrs

INR 0 - 1 Lacs

Executive - Technology Transfer(Formulations)

Hyderabad/Secunderabad

4.0 - 7.0 yrs

INR 3 - 5 Lacs

Junior Scientist - Analytical Development(Injectables)

Hyderabad/Secunderabad

3.0 - 6.0 yrs

INR 1 - 6 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.