Quality Manager at UNOCASA Limited

Job Description

• Ensure produucts manufactured and imported are consistently of high quality, efficacious and safe for patients in line with company’s internal requirements whilst complying with requirements of NAFDAC and WHO cGMP guidelines.

Duties and Responsibilities

• Overall management of Quality Assurance and Quality Control activities in the business.
• Work with the technical director to develop and implement departmental strategic goal and objectives.
• In-charge of product Batch release in line with cGMP Guidelines (NAFDAC andWHO).
• Ensures qualification of all plant & quality control equipment, validation of manufacturing processes, cleaning processes and analytical methods are planned for and subsequently carried out according to the VMP.
• Ensure that Quality Control and IPC testing are carried out using validated methods before release of any product.
• Ensure proper investigation of all products related Customer Complaints and deviations, according to WHO cGMP guidelines.
• Maintenance of the Company’s quality policy and ensure thecascade to all new and existing staff
• Review, of the site master file in conjunction with other stakeholders asrequired.
• Ensure GMP related trainings are carried out in line with the approved training plan andprocedure.
• Ensure routine self-inspection and preparation of the business for all external audits.
• Management of recall of products, out of specification resultsand deviations as well as change control.
• Ensure management of stability studies via periodic evaluation of the results of accelerated and follow up stability studies.
• Manage annual product quality reviews activities.
• Prepare and manage the departmental OPEX and CAPEX ensuring that expenses are kept within acceptable limits.
• Ensure that product and promotional artwork are well proofread having the right placement of logo and colour conformances on materials before final approval and release.
• Certify that all new products developed meet defined product requirement as well as participate in products developed done by the Company or thirdparty.
• Conduct at least an annual quality management reviewmeeting.
• To ensure in liaison with other stakeholders for the destruction of rejected materials or products in line with NAFDAC regulations.
• To ensure proper storage, and retrieval of all quality records
• Manages the qualification and approval for new and existing vendors.
• To ensure discipline of QA/QC personnel in conjunction with the HRDirector.
• Ensure adherence to quality/ warehouse agreement by third party distribution and warehousing partners; and monitoring of warehouses and Third-party distribution (e.g.,MDS)
• Ensure adequate and effective communication system within and outside the department.
• Authorize written procedures, sampling instructions, specifications, test methods and other documents including amendments.
• Ensure maintenance of the department, facilities, premises, andequipment
• Ensure monitoring and control of the manufacturing environment and the entire plant hygiene.
• To perform any other duties as may be assigned from time to time by the Technical Director & Managing Director.

Educational Qualifications

• B.Sc in Pharmaceutical, Physical Sciences and other Science-related disciplines
• Computer literacy and Microsoft Office ProficiencyTechnical Skills:
• Quality Management Skills
• Managerial and People management skills
• Integrity, sound technical knowledge and good decision-makingskills
• Auditing skills, critical evaluation skills.
• Data Analysis, Report Writing and Presentation skills
• Problem solving and analytical skills Required Experience: Minimum of 8 years practical experiences in pharmaceuticals with a minimum of 5 years in the same capacity as Quality Manager with knowledge of WHO cGMP guidelines.