We’re looking for a candidate to fill this position in an exciting company.
Ensure adherence to quality procedures, regulatory requirements and cGMPs.
Review and approve deviations according to site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the root cause analysis and associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/stability/regulatory impact.
Handle product complaints. Ensure complaints are investigated thoroughly with effective CAPAs to prevent recurrence.
Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks. Conduct internal audits to ensure the internal controls are effective.
Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
Support the maintenance of validated stated of GMP systems and processes.
Support regulatory submissions and attend to regulatory queries in a timely manner.
Min Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
Min Diploma in Science related discipline with a minimum of 10 years experience in Quality Assurance role within the pharmaceutical industry will be considered.
Minimum 4 years experience in a Quality Assurance role within the pharmaceutical industry. Compliance, regulatory or validation experience is an advantage.
Strong written and oral communication skills. Technical report writing skills is an advantage.