Trainee Executive: IRF Analytical

Lupin; Nashik District; On-site; INR 420,000 - 700,000; Full time

Job summary

Lupin in Nashik, India seeks an Analytical Method Development scientist with 0-5 years of experience to drive assay development and dissolution methods using chromatographic techniques. The role includes method validation, transfers, and preparation of specifications and development reports.

It also involves maintaining GLP records, providing timely regulatory support, and supporting site QC investigations as needed.

Qualifications

• Analytical Method Development for assays and dissolution by chromatographic methods.
• Experience in method validation and transfer between facilities.
• Prepare specifications, standard test procedures, and development reports for drug products and excipients.
• Maintain GLP documents and ensure compliance.
• Provide timely support in resolving regulatory queries.
• Support site QC investigations as needed.

Responsibilities

• Develop analytical methods for API and finished products.
• Validate methods and support transfers.
• Prepare specifications and development reports.
• Maintain GLP documentation.
• Address regulatory queries promptly.
• Support QC investigations at the site.

Skills

Analytical method development

Method validation

Method transfer

GLP compliance

Regulatory support

QC investigations

Education

Masters in Analytical Chemistry or Pharmacy

Job description

• Analytical Method Development (e.g. Assay Related substance and dissolution by Chromatographic methods)
• Analytical method validation and method transfer.
• Preparation of specification, standard test procedure, Method development Reports of drug products and excipients.
• Maintenance and upkeep of the GLP documents.
• To provide timely support in resolving regulatory quires.
• To help and supports site QC investigations

Work Experience

0-5 y

Education

Masters in Analytical Chemistry or Pharmacy

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