Data integrity Specialist

Job Description:

• Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA principles and regulatory standards (21 CFR Part 11, Annex 11).
• Review audit trails, monitor user access, and perform periodic data reviews.
• Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation.
• Perform titration-based content uniformity tests as per SOPs and pharmacopeial guidelines (USP, IP, BP); calculate active ingredient content and assess batch uniformity.
• Ensure compliance with GLP, GMP, and good documentation practices; maintain validated systems with secure electronic records and audit trails.

• Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon, etc.).
• Ensure adherence to ALCOA principles and regulatory requirements (21 CFR Part 11, Annex 11).
• Review audit trails, monitor user access, and perform periodic data reviews.
• Maintain accurate documentation of chromatograms, integration parameters, and calculations.

• Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II).
• Conduct root cause analysis, hypothesis testing, and propose CAPAs.
• Document investigation narratives and track CAPA effectiveness.

• Perform titration-based content uniformity tests per SOPs and pharmacopeial guidelines (USP, IP, BP).
• Calculate active ingredient content and assess batch uniformity.

• Ensure compliance with GLP, GMP, and good documentation practices.
• Maintain validated systems with secure electronic records, audit trails, and backup protocols.
• Review and approve titration method logs, normality calculations, and endpoint determinations.