GMP Quality & Compliance Specialist — Data Integrity

Piramal Pharma Limited; Riverview, Northern (MI, KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), Riverview, Michigan, seeks a qualified Quality and Compliance Specialist to join our Quality Control team. The specialist reviews laboratory data and ensures methods and procedures meet GMP and data integrity standards, with responsibility for the release of some GMP materials.

Candidates should hold a Bachelor’s degree in Chemistry or a related field and have 2–5 years of experience with HPLC, GC, and

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• 2–5 years of experience with HPLC, GC, and related analytical techniques.
• QC data review experience is a plus.

Responsibilities

• Review IPC, raw materials, intermediates, and finished products analytical data according to cGMP and data integrity standards.
• Release of starting materials and cleaning validations/verifications for GMP manufacturing.
• Review deviations for accuracy and compliance; support investigations (OOS, CAPAs).
• Document review includes samples, equipment setup, test results and audit trails.

Education

Bachelor’s degree in Chemistry, Biochemistry or related field

Tools

HPLC

GC

IR

KF

TGA

DSC

LIMS

OpenLab

SAP

Trackwise

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), Riverview, Michigan, seeks a qualified Quality and Compliance Specialist to join our Quality Control team. The specialist reviews laboratory data and ensures methods and procedures meet GMP and data integrity standards, with responsibility for the release of some GMP materials.

Candidates should hold a Bachelor’s degree in Chemistry or a related field and have 2–5 years of experience with HPLC, GC, and