GMP Quality & Compliance Specialist — Data Integrity

Piramal Pharma Ltd; Ipswich City; On-site; AUD 108,000 - 158,000; Full time

Job summary

Piramal Pharma Solutions’ HPAPI QA facility located in Riverview, Michigan, seeks a qualified Quality and Compliance Specialist to join the Quality Control team. The role focuses on reviewing laboratory data to ensure analytical accuracy, protocol compliance, and proper documentation for GMP materials release.

The ideal candidate has a chemistry degree, 2–5 years of GMP lab experience, and proficiency with HPLC/GC.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry or related field.
• Minimum two (2) to five (5) years of experience in using HPLC, GC, and/or related analytical techniques. QC data review experience 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, as well as cleaning validation/verification data according to cGMP, GDP, in a timely manner.
• Release of starting materials, raw materials, and cleaning validations/verifications for GMP manufacturing
• Interface with their supervisor, the analytical group(s) and QA on a daily basis.
• Review of deviations for accuracy, completeness and compliance to data integrity, written procedures, and cGMP regulations
• Document review includes review of sample preparation, equipment set-up, and test results in laboratory notebooks or other appropriate test record forms, and electronic data and audit trails
• Review of a variety of data types including HPLC, GC, KF, IR, XRPD, ICP, TGA, DSC, and wet chemistry testing
• Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc.
• Perform and or support lab investigations (e.g. OOS, deviations, CAPAs)
• Assist in the preparation of new or revised documentation as required.
• Participate in the implementation of continuous improvement initiatives as they relate to quality activities (e.g., introduction of new technology and automation with respect to data acquisition, electronic review, quality management systems, LIMS, etc.)
• Revise via change control documentation as required
• Perform other related assignments and projects as required

Skills

Analytical data review

Attention to detail

Strong written/verbal communication

Organizational skills

Team collaboration

Education

Bachelor’s degree in Chemistry, Biochemistry or related field

GMP laboratory experience

Technical writing experience

Tools

ECM OpenLab

SAP

Trackwise

LIMS

Job description

Piramal Pharma Solutions’ HPAPI QA facility located in Riverview, Michigan, seeks a qualified Quality and Compliance Specialist to join the Quality Control team. The role focuses on reviewing laboratory data to ensure analytical accuracy, protocol compliance, and proper documentation for GMP materials release.

The ideal candidate has a chemistry degree, 2–5 years of GMP lab experience, and proficiency with HPLC/GC.