GMP Quality & Compliance Specialist - Data Integrity Expert

Piramal Pharma Limited; Riverview; On-site; GBP 48,000 - 67,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC) in Riverview, Michigan, seeks a Quality and Compliance Specialist to join our Quality Control team. You will review laboratory data, ensure methods and procedures are followed, and help ensure GMP and data integrity across analyses.

Responsibilities include data review of HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry tests; release of materials; and supporting investigations and documentation

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• 2–5 years’ experience with HPLC, GC, and related analytical techniques; QC data review a plus.
• Knowledge of ECM OpenLab, SAP, Trackwise, LIMS a plus.
• Technical Writing Experience.
• Minimum two (2) years of GMP laboratory experience.

Responsibilities

• Review IPC, raw materials, intermediates, and finished products analytical data and cleaning validation/verification per cGMP.
• Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing.
• Interface with supervisor, analytical group(s) and QA daily.
• Review deviations for accuracy, completeness and data integrity, SOPs, and cGMP regulations.
• Review reports for accuracy and completeness (method validation, stability, calibration/PM reports).
• Perform and/or support lab investigations (OOS, deviations, CAPAs).
• Assist in preparation of new or revised documentation.
• Participate in continuous improvement initiatives related to data acquisition, electronic review, QMS, LIMS, etc.
• Revise via change control documentation as required.
• Perform other related assignments and projects as required.

Skills

HPLC

GC

Data analysis

Quality systems

cGMP

Education

Bachelor’s degree in Chemistry or Biochemistry

Tools

ECM OpenLab

SAP

Trackwise

LIMS

Job description

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC) in Riverview, Michigan, seeks a Quality and Compliance Specialist to join our Quality Control team. You will review laboratory data, ensure methods and procedures are followed, and help ensure GMP and data integrity across analyses.

Responsibilities include data review of HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry tests; release of materials; and supporting investigations and documentation