Senior Analyst
Mallinckrodt Enterprises LLC
Apply to this job India - Pudupakkam Until 9/22/2026 5+ years exp First posted July 24, 2026 Last posted July 24, 2026
Job description
Job Description Summary
Responsible for performing complex analytical activities, reviewing and interpreting data, ensuring compliance with applicable procedures and regulatory requirements, and providing technical guidance to team members. The role involves executing and reviewing laboratory analyses, investigating atypical results (OOS/OOT/OOA), supporting method validations and stability studies, preparing technical documentation, and driving continuous improvement initiatives. The Senior Analyst collaborates with cross-functional teams to resolve quality-related issues, maintain data integrity, ensure timely completion of assigned activities, and support regulatory inspections and audits while adhering to current GMP and company quality standards.Job Description
- Perform routine, stability, validation, and investigation sample analysis using HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, TOC, and other QC laboratory instruments.
- Execute analytical testing of raw materials, packaging materials, in-process samples, finished products, and cleaning validation samples as per approved specifications and test methods.
- Ensure accurate documentation of analytical results in compliance with GDP, cGMP, and data integrity requirements.
- Prepare and standardize volumetric solutions, reagents, and reference standards as per established procedures.
- Investigate OOS, OOT, OOA, deviations, and laboratory incidents.
- Participate in audit and inspection readiness activities.
- Drive continuous improvement and laboratory efficiency initiatives.
About this role
Summary
Perform analytical testing, document results, investigate deviations, support audits, ensure quality standards.
Job title
Senior Analyst
Experience level
senior level
Minimum experience
5+ years exp
Industry
pharmaceutical
Location requirements
Pudupakkam, India; remote not specified
Salary
Not specified
Management role
No
Skills & keywords
Required skills
HPLCGCUV-Vis Spectrophotometrydissolution apparatusOOS/OOT investigationregulatory compliance
Preferred skills
method validationdata integrityaudit readinesscontinuous improvement
Specializations
analytical testingregulatory complianceGMPHPLCGC
Locations
Structured locations inferred from the posting.
Pudupakkam, Tamil Nadu 603103, India
On-site City
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