Recruiter: Mafservice Global Resource ltd. Job Title: Quality Control Lead Industry: Health Location:Wuse Zone5 Male/Female: Both Male/female Age:20yrs and above List of Duties: • Travel to sponsor sites to QA reviews of clinical trials and processes for adherence to SOPs, policies, and NHREC and NAFDAC guidelines • Prepare reports and discuss non-compliance and quality findings with sponsors and within the organization to identify solutions and action plans • Provide guidance and root-cause analysis to mitigate identified challenges and gaps in processes • Work closely with clinical teams and Principal Investigator as needed to identify gaps and ensure continuous process improvement • Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate • Implements quality management plans including risk identification and assessment through data review and quality control processes • Provides consultation and corrective action plans in a timely manner and identifies preventative actions for site staff and clinical trial operations. • Provides guidance on relevant updates to assist with the improvement and updates in relevant SOPs, policies, and training as needed • Conducts Quality Assurance training for employees and new hires when needed • Conducts review of training records and identified SOPs to ensure assigned sites are maintaining compliance with training curriculum • Stay up to date on relevant clinical trial requirements, NAFDAC, NHREC, GCP, ICH, and other relevant guidelines within Sub-Saharan Africa and other regions relevant for the organization • Identify and escalate significant compliance issues as according to SOPs • Identify training gaps and ensure periodic training for the organization employees • Assist with quality incident and compliance investigations as required Experience Needed: - Three to five(3-5) years experience in same field - Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits also preferred Educational Level: Minimum of BSC in related Field Core Competency and Skills: • Strong working knowledge of medical terminology, SOPs, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), applicable regulatory requirements, and quality management processes • Direct experience in the conduct and reporting of internal and external audits preferred • Excellent interpersonal, verbal, and written communication skills • Client and patient-focused approach • Thrives in a fast-paced environment with the ability to work independently, be proactive, and have a nimble approach with respect to day-to-day activities • Ability to multitask and prioritize workload with attention to detail and strong organizational skills • Ability to work effectively with cross-functional teams to foster teamwork within the group and beyond • Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams. • Maintains a strong level of integrity and good judgement at all times • Experience of inspection management • Fundamental knowledge of in-country and international regulatory standards and guidelines for the conduct of clinical trials • Knowledge of data integrity controls and systems quality for clinical area • Strong analytical skills and report writing skills • Ability to demonstrate tact as a representative of the CQA Department • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently • Ability to Travel (approximately 25%) Necessary certificates, licences and registrations: Nil Salary: 250k-400k Additional benefits: Nil Working time: 8:30am-5:00pm Working Days: Mon-Fri Accomodation: No Feeding: No Guarantor: Yes Vacancy Codes: 12025 APPLICATION PROCESS To apply, kindly send a screenshots of the vacancy to the provided email below to initiate your job application process, subject should be the title of the job you are applying for. Email: [email protected] To view other jobs available in same State please join our telegram channel or WhatsApp Channel Our Abuja Telegram Channel: Channel: https://t.me/mafservicejobsabuja Our Lagos Telegram Channel: https://t.me/mafservicejobslagos Our Abuja WhatsApp Channel: https://whatsapp.com/channel/0029VakVYeR5a249zYFXLt0d Lagos WhatsApp Channel: ‎https://whatsapp.com/channel/0029Vap6OuEADTOLTyfFXI2X