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Analyst, Global Stability at Keenova Therapeutics and Par Health - ApplyBlast

Analyst, Global Stability

Keenova Therapeutics and Par Health

3 months ago

3.4 on Glassdoor

Pudupakkam, Tamil Nadu, India

Onsite

Full Time

Senior

0 applicants

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About this role

An experienced Analytical/Quality Control Analyst performs routine testing on drug products and raw materials using techniques like HPLC and GC within an FDA-regulated environment. The role involves ensuring data integrity, maintaining stability samples, and investigating out-of-specification results while adhering to cGMP and GLP standards. Candidates must be proficient in operating analytical instruments, documenting processes, and supporting regulatory audits.

Responsibilities

Perform routine and stability sample analysis using approved methods
Operate and maintain analytical instruments such as HPLC and GC
Investigate out-of-specification results and support deviation activities
Ensure compliance with FDA regulations and data integrity principles
Prepare analytical reports and participate in method validation activities

Skills

About Keenova Therapeutics and Par Health

mallinckrodt.com

Headquarters

Dublin, Dublin, Ireland

Company Size

1001-5000 employees

Founded

1867

View Profile

Keenova Therapeutics and Par Health are the successor entities formed after Mallinckrodt's merger with Endo; Keenova Therapeutics focuses on specialty therapeutics across rare and unaddressed conditions (immunology, urology, hepatology, ophthalmology, orthopedics, critical care), while Par Health develops high-quality generics, sterile injectables, and active pharmaceutical ingredients (APIs) with a robust U.S.-advantaged manufacturing network.