Endo

Analyst, Global Stability

Endo  •  Republic of India (Onsite)  •  8 days ago
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Job Description

Experienced Analytical/Quality Control Analyst with 3–5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.

  • Perform routine and stability sample analysis as per approved specifications and test methods
  • Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
  • Review and document analytical data in compliance with cGMP and data integrity principles
  • Investigate OOS/OOT results and support deviation and CAPA activities
  • Ensure compliance with FDA, cGMP, and GLP requirements
  • Prepare and review analytical reports, protocols, and SOPs
  • Participate in method transfer, verification, and validation activities
  • Support regulatory and internal audits

Key Skills:

  • Strong knowledge of FDA regulations, cGMP, and data integrity
  • Analytical troubleshooting and problem-solving skills
  • Documentation and compliance expertise
  • Team collaboration and communication
Endo

About Endo

Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.

From this union, we established two focused, standalone companies:

– Keenova Therapeutics, a branded therapeutics business

– Par Health, a generics and sterile injectables business

To learn more, follow Keenova and Par Health on LinkedIn and visit keenova.com and parhealth.com.

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Malvern
Year Founded
Unknown
Website
endo.com
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