Analyst, Global Stability
Mallinckrodt Enterprises LLC
Apply to this job India - Pudupakkam Until 8/27/2026 3+ years exp First posted June 28, 2026 Last posted June 28, 2026
Job description
Job Description Summary
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.Job Description
- 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
About this role
Summary
Perform analytical testing, operate instruments, ensure regulatory compliance, and support audits.
Job title
Analyst, Global Stability
Experience level
3-5 years
Minimum experience
3+ years exp
Industry
pharmaceutical
Location requirements
India - Pudupakkam, on-site; remote not mentioned
Salary
Not specified
Management role
No
Skills & keywords
Required skills
FDA regulationscGMPdata integrityanalytical troubleshootingdocumentation
Preferred skills
None specified
Specializations
analytical testingHPLCGCUVdissolution
Locations
Structured locations inferred from the posting.
Pudupakkam, Tamil Nadu 603103, India
On-site City
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