Quality Control Sr Analyst

Piramal Pharma Limited; Sellersville (Bucks County); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

The Senior Quality Specialist, Laboratory Investigations & Data Integrity at Piramal Pharma Solutions leads laboratory investigations, OOS/OOT assessments, and CAPA development within a cGMP pharmaceutical laboratory.

Reporting to the Associate Director, Quality Control, the role applies scientific and regulatory judgment to determine root cause, assess product and data impact, document defensible conclusions, and drive timely actions to closure.

Competenze

• Experience leading laboratory investigations in a cGMP environment.
• Familiarity with OOS/OOT assessments and CAPA processes.
• Strong focus on data integrity and compliant documentation.

Mansioni

• Lead and complete laboratory investigations, including OOS/OOT assessments.
• Review analytical data and determine root cause and product impact.
• Document defensible conclusions and drive timely CAPA closure.

Conoscenze

Laboratory investigations

OOS/OOT assessments

CAPA development

Data integrity

Descrizione del lavoro

Division

Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.For more details, please visit : www.piramalpharmasolutions.com

Job Title

Quality Control Sr AnalystJob Description

POSITION SUMMARY

The Senior Quality Specialist, Laboratory Investigations & Data Integrity is an experienced Quality Control individual contributor responsible for leading and completing laboratory investigations, OOS/OOT assessments, CAPA development, and comprehensive review of analytical data in a cGMP pharmaceutical laboratory. Reporting to the Associate Director, Quality Control, the role applies scientific and regulatory judgment to determine root cause, assess product and data impact, document defensible conclusions, and drive timely actions to closure.

The position builds on the Senior QC Analyst technical foundation and retains the ability to understand and evaluate analytical testing of raw materials, finished products, stability samples, and special-request samples. The specialist independently reviews paper and