Compliance Lead

Compliance Lead - Clean Utilities

Responsibilities

Compliance Management & Oversight

• Manage overall compliance workload for clean utilities systems (tracking, resources, prioritisation)
• Ensure timely completion of QMS tasks (deviations, CAPA, change controls) related to clean utilities equipment and processes
• Coordinate inspection/audit preparation and response for clean utilities systems (WFI, Purified Water, Clean Steam, HVAC, Compressed Air)
• Drive reductions in deviations and discards attributable to clean utilities engineering failures or non-conformance's
• Monitor training completion, periodic reviews, and document revisions for clean utilities SOPs and equipment protocols

Clean Utilities Engineering Compliance

• Ensure compliance of clean utilities systems with cGMP, EU GMP Annex 1, FDA guidelines, and pharmacopeial standards (USP, EP, JP)
• Oversee qualification and validation activities for clean utilities equipment (IQ/OQ/PQ, requalification cycles)
• Monitor critical quality attributes (CQAs) and critical process parameters (CPPs) for water systems, clean steam, and compressed gases
• Maintain compliance with microbiological and chemical testing requirements for clean utilities
• Ensure proper sanitation, passivisation, and maintenance protocols are followed and documented

Data Integrity & Quality Oversight

• Serve as data integrity champion for clean utilities systems, ensuring adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
• Conduct regular data integrity assessments and audits of clean utilities monitoring systems, electronic records, and paper-based documentation
• Oversee implementation and maintenance of 21 CFR Part 11 and EU Annex 11 compliant systems for clean utilities data capture and storage
• Review and approve data governance procedures, including audit trail reviews, electronic signature protocols, and backup/archive strategies
• Investigate data integrity incidents and implement corrective actions to prevent recurrence
• Ensure proper controls are in place to prevent data manipulation, deletion, or unauthorised access
• Monitor user access rights and system security for clean utilities SCADA, historians, and laboratory information management systems (LIMS)
• Verify that all clean utilities testing data (chemical, microbiological, conductivity, TOC) is captured, reviewed, and retained in compliance with regulatory requirements

Quality Systems & GMP Oversight

• Lead quality oversight of clean utilities operations, ensuring all activities comply with site quality standards and regulatory expectations
• Perform periodic quality reviews of clean utilities systems to identify trends, risks, and improvement opportunities
• Ensure proper implementation of quality risk management (QRM) principles per ICH Q9 for clean utilities systems
• Oversee change control processes for clean utilities modifications, ensuring proper impact assessments and quality approvals
• Verify that all clean utilities deviations are properly investigated with appropriate depth and rigor
• Ensure laboratory testing for clean utilities meets compendial requirements and data is scientifically sound
• Monitor out-of-specification (OOS) and out-of-trend (OOT) results for clean utilities parameters and ensure proper investigation protocols
• Maintain quality agreements and oversight of third-party vendors supporting clean utilities systems

Technical & Engineering Support

• Lead root cause analysis (RCA) for clean utilities-related deviations using engineering investigation techniques (5-Why, Fishbone, FMEA)
• Provide technical expertise on clean utilities system design, operation, and troubleshooting
• Review and approve engineering changes, modifications, and upgrades to clean utilities infrastructure
• Interface with Engineering, Quality, Operations, and Validation teams on clean utilities compliance matters
• Support continuous improvement initiatives to enhance system reliability and reduce compliance risks

Documentation & Reporting

• Maintain accurate and complete documentation for clean utilities systems in compliance with data integrity (ALCOA+) principles
• Generate compliance metrics, trend analysis, and performance dashboards for clean utilities systems
• Prepare technical reports for regulatory inspections and internal audits
• Ensure proper calibration and maintenance records for clean utilities monitoring and control equipment
• Conduct periodic document reviews to ensure accuracy, completeness, and regulatory compliance
• Oversee electronic batch record (EBR) and manufacturing execution system (MES) data related to clean utilities

Requirements & Qualifications

Expected Experience

• 5+ years of experience working in pharmaceutical manufacturing with direct exposure to clean utilities systems
• 3+ years in a compliance, quality, or engineering role within a GMP environment
• Demonstrated experience with clean utilities qualification, validation, and ongoing compliance monitoring
• Experience supporting regulatory inspections (FDA, EMA, or other health authorities)
• Track record of leading investigations and implementing effective CAPAs
• Proven experience with data integrity oversight, audits, and remediation activities
• Experience with computerised systems validation (CSV) and electronic records compliance
• Expected Technical Skills

Education & Certifications

• Engineering degree (Chemical, Mechanical, or related discipline) or scientific degree (Chemistry, Microbiology, Pharmaceutical Sciences)
• Additional certifications in GMP, validation, quality systems, or data integrity (e.g., ASQ CQE, ISPE, GAMP, Data Integrity certification) are advantageous
• Technical Expertise
• In-depth knowledge of GMP quality systems and regulatory requirements (21 CFR Part 211, EU GMP Annex 1, ICH Q7)
• Strong understanding of clean utilities engineering principles: water systems (WFI, PW), clean steam generation, HVAC, compressed gases
• Knowledge of pharmacopeial requirements (USP ?643>, ?645>, ?1231>; EP 2.2.44, 5.1.4)
• Proficiency with qualification and validation methodologies (IQ/OQ/PQ, CSV)
• Expert knowledge of data integrity requirements: ALCOA+, 21 CFR Part 11, EU Annex 11, MHRA/FDA data integrity guidance
• Understanding of electronic systems used in clean utilities: SCADA, historians, PLC/DCS, LIMS, chromatography data systems (CDS)
• Facility with quality management system (QMS) software (e.g., TrackWise, MasterControl, Veeva)
• Understanding of process instrumentation, automation, and control systems
• Knowledge of audit trail review practices, electronic signature requirements, and system security controls

Please note that this is a shift pattern role - 2 shift with some on-call shifts.