Dedicated Quality Compliance Officer (GMP / Aseptic / Sterile Pharmaceutical Manufacturing)

URGENT HIRING | 11 OPENINGS
The DQCO performs independent, real-time oversight of all GMP activities at the facility, without direct involvement in production or routine quality release (QA release / QC). The role ensures that aseptic compliance, data integrity, environmental monitoring, and contamination control are maintained to the highest regulatory standards across all production shifts.
1. Aseptic Compliance Monitoring (6 headcounts)
Real-Time Floor Monitoring:
• Perform continuous observation within sterile areas across all production shifts.
• Monitor aseptic techniques and interventions, operator behavior and gowning practices, material and personnel flow, and cleanroom discipline.
• Verify adherence to approved procedures and GMP requirements.
CCTV Review & Documentation:
• Review CCTV footage of critical operations and interventions.
• Cross-reference documented records against observed actual practices.
• Record all aseptic deviations immediately and in full detail.
Media Fill & Training Support:
• Observe and document activities during aseptic process simulations (media fills).
• Provide feedback to operator training programmes to improve aseptic behaviour.
• Perform routine and unannounced inspections in GMP areas.
2. Data Integrity Oversight & System Compliance - (1 headcounts)
GMP Records Verification:
• Cross-reference batch production records (BPR), log books, and actual instrument/system data.
• Ensure all GMP records comply with ALCOA+ principles: Attributable, Legible, Contemporaneously recorded, Original, Accurate (plus Complete, Consistent, Enduring, and Available).
• Cross-check recorded data against actual on-floor activities.
Audit Trail & Electronic Systems Review:
• Review audit trails of LIMS, MES, SCADA, and other GMP data systems.
• Detect indicators such as back-dated entries, unauthorised corrections, or missing data.
• Verify system access controls and data modification history.
DI Investigation & Training:
• Support Data Integrity awareness training and education for GMP personnel.
• Initiate a formal Data Integrity investigation within 24 hours of detecting a breach.
3. Environmental Monitoring & Microbiology Oversight - (2 headcounts)
Microbiology Operations Observation:
• Observe environmental sampling procedures (Active Air Sampling, Settle Plate, Contact Plate, Personnel Monitoring).
• Monitor plate reading, incubation procedures, and Growth Promotion Testing.
• Detect analyst bias or manipulation in the interpretation of environmental monitoring (EM) results.
EM Data Review:
• Perform daily review of viable and non-viable environmental monitoring data.
• Verify compliance with Alert Limits and Action Limits.
• Trend contamination data and detect early adverse signals.
• Initiate immediate investigation for excursions and atypical findings.
Contamination Investigation Support:
• Participate in contamination incident investigations and source identification.
• Recommend investigation initiation and batch impact assessment.
4. Cleaning, Disinfection & Contamination Control (CCS Oversight) - (1 headcount)
Execution Oversight:
• Oversee execution of cleaning and disinfection procedures against approved SOPs.
• Verify disinfectant contact times and confirm disinfection effectiveness.
• Ensure disinfectant rotation is performed correctly and on schedule.
• Audit cleaning records versus actual practices (including CCTV verification).
Contamination Control:
• Ensure adherence to the Contamination Control Strategy (CCS) across all operations.
• Evaluate cleaning validation results and assess residue risk.
• Identify gaps in cleaning effectiveness and recommend improvements.
• Immediately escalate cleaning failures and recommend production hold when necessary.
5. Observation Reporting, Escalation & CAPA - (1 headcount)
Real-Time Observation Documentation:
• Record all observations in real time using standardised controlled forms.
• Classify deviations: Critical (immediate escalation) / Major (within 24 hrs) / Minor (routine review).
• Notify Management of all critical issues without delay.
Investigation & CAPA Participation:
• Participate in root cause analysis (RCA) for identified deviations.
• Review CAPA plans, verify implementation, and monitor for recurrence.
• Support CAPA effectiveness checks and report findings to management.
Inspection Readiness
• Maintain observation records, reports, and forms in a continuously retrievable, inspection-ready state.
• Support FDA and other regulatory authority inspectors during inspections.
• Provide records and evidence of DQCT oversight activities upon request.