GMP Quality & Data Integrity Specialist

Piramal Pharma Solutions; Riverview (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan seeks a qualified Quality and Compliance Specialist to join our Quality Control team. The role reviews laboratory data and reports to ensure accuracy, integrity and GMP compliance, with responsibility for release of certain GMP materials.

Key tasks include data review of HPLC, GC, KF and other tests, deviation investigations, and alignment with QA and engineering on continuous improvement of data systems

Qualifications

• Bachelor's degree in Chemistry, Biochemistry or related field.
• 2–5 years of GMP laboratory data review experience.
• Experience with HPLC, GC or related analytical techniques is a plus.
• Technical writing experience.

Responsibilities

• Review analytical data, raw materials, intermediates and finished products per cGMP standards.
• Release of starting materials and cleaning validations/verifications for GMP manufacturing.
• Interface with supervisor, analytical groups and QA daily.
• Review deviations for accuracy and data integrity, procedures, and cGMP compliance.
• Review reports for accuracy and completeness (method validation, stability, calibration).
• Support investigations (OOS, deviations, CAPAs) when needed.
• Assist in preparing updated or new documentation as required.
• Participate in continuous improvement initiatives related to data acquisition and electronic review.

Skills

GMP compliance

Data integrity

Quality control

Documentation

Education

Bachelor's degree in Chemistry or Biochemistry

Tools

ECM OpenLab

SAP

TrackWise

LIMS

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, Michigan seeks a qualified Quality and Compliance Specialist to join our Quality Control team. The role reviews laboratory data and reports to ensure accuracy, integrity and GMP compliance, with responsibility for release of certain GMP materials.

Key tasks include data review of HPLC, GC, KF and other tests, deviation investigations, and alignment with QA and engineering on continuous improvement of data systems