Quality Assurance Specialist

Responsibilties:

Quality documents (QDs):

• Support the implementation of a practical, user-friendly, compliant system for the management of Xcene Clinical QDs
• Support the overall life-cycle management of Clinical QDs (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement)
• Support development of QDs for the CQA function
• Review all other Clinical QDs for compliance with regulations, company policies, other QDs
• Ensure availability of current QDs to all Xcene staff on an electronic platform
• Provide controlled copies to external parties
• Support gap analyses of processes
• Support process improvement and QD optimization activities

Training:

• Support company approach for staff training by providing or coordinating training (e.g., GCP, QA, Risk Management, QDs)
• Support maintenance of system to ensure availability of clinical staff training records (CVs, JDs, training logs & records)

Clinical trial support & optimisation:

• Replace CQA Leader or Senior CQA Manager at Extended Disease Team meetings when needed
• Be an ad hoc member of trial teams, attend meetings as needed, and review meeting minutes
• Attend other meetings as required, in line with need/internal procedures
• Act as a GCP expert/consultant and provide expertise, support, and/or respond to questions from clinical staff on GCP/QA questions
• Provide support with interpretation of regulatory guidelines
• Support CQA Leader input to QA section of Clinical Development Plans, where applicable
• Identify potential risks in trial management activities and communicate these to the trial responsible and CQA Leader
• Develop and maintain GCP/ICH-compliant processes which control the quality of work and clinical trials conducted at Xcene Research.
  
• Actively lead or assist activities in the areas of internal quality audits, CAPA (corrective and preventive actions), production support, quality management reviews, and quality audits.
• Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
• Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.
• Assist with management of contract auditors.
• Assist in conducting vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves

Audits/Quality Control:

• Provide input to the audit plan from discussions/feedback with trial teams
• Support management of outsourced audit activities, including liaison with auditee and Xcene Research contact, review of draft audit reports
• Liaise with the auditee for the completion of a Corrective/Preventive Action Plan (CAPA plan) and oversee follow-up and timely close-out of CAPA
• Feed information into the tracking tool to be able to provide trends on audits and audit findings
• Perform quality control reviews of key trial documents (protocols, informed consent forms, clinical study reports, investigator brochures, and others if requested)

Inspections (or external audits):

• Support inspection preparation activities and may be called upon to remain with inspector(s) during inspection
• Provide support to develop and feedback on the inspection CAPA
• Feed information into the tracking tool for trends on audits and audit findings

Risk Management:

• Follow and maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
• Support clinical staff to implement the deviation process
• Support Risk Management Plans for clinical activities
• Support risk management and risk mitigation activities
• Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues
• Ensure escalation to CQA Leader of major or critical quality issues or risks
• Participate in regular CQA meetings to discuss QA/GCP issues and align/harmonize approach.

Xcene Subsidiaries:

• Implement and maintain the Quality Assurance Program to monitor, measure, assess, and continuously improve the quality of subsidiary services, including laboratory, manufacturing, and pharmaceutical distribution operations.
• Provide technical guidance, support, and consultation to subsidiary-facing staff on GLP, GMP, and QA-related matters, including interpretation and application of relevant requirements.
• Analyze and interpret applicable standards, guidelines, regulations, and legislation, and support the subsidiary in maintaining compliance with relevant requirements.
• Support the overall life-cycle management of Quality Documents (QDs) for the different processes/departments of the subsidiary (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement).

Requirements:

• 1-3 year of experience with quality management.
• Bachelor’s degree (or equivalent) level of qualification in life science, pharmaceutical science or a related field or an equivalent combination of education and experience.
• Sharp attention to details
• Willingness to work with multiple supervisors in a matrix environment and to value the importance of teamwork.
• Ability to understand, apply, and explain concepts.
• Ability to work professionally with highly confidential information.
• Ability to lead and manage multiple responsibilities.
• Ability to learn and apply Lean and/or Six Sigma management practices
• Knowledge of laboratory operations and workflows including pre-analytical, analytical, and post-analytical phases of testing
• Knowledge of Good Distribution Practice and basic knowledge of GMP
• Be willing to travel when necessary
•  Must have thorough knowledge of clinical research concepts, practices, and FDA regulations, country local regulations, NAFDAC regulations, EU regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods. 
• Encouraged to have a working knowledge of Good Laboratory Practice and/or Good Manufacturing Practice
• Expertise in quality management with demonstrated ability to effectively manage multiple projects and people.
• Possess ISO 9001 certification.
• Knowledge of Quality Improvement, Lean and/or Six Sigma training.
• Proactive problem-solving abilities and follow-through. 
• Ability to work in a very dynamic environment of scientifically driven biotech, with limited resources and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems. 
• Demonstrated ability to maintain current knowledge of quality, GCP, and GLP/GMP requirements and guidance to support compliance with applicable global regulatory standards and legislation.

Location: Lagos

Remuneration: NGN350,000 - 400,000 Monthly