Quality Manager at UNOCASA Limited

Job Summary

Our client is seeking a proactive and motivated Quality Manager to provide Quality related technical services aimed at ensuring that products manufactured and imported for sale are consistently of High Quality, efficacious and safe for our patients in line with Organisation’s internal requirements/standards and other International standards whilst also complying with requirements of National Agency for Food Drug Administration and Control (NAFDAC); WHO cGMP guidelines and Quality Management System.

Job Duties & Responsilbilites

• Overall management of all Quality Assurance and Quality Control activities in the business ranging from Product quality, Material testing, Quality Management System, Quality Improvement programs & Quality Culture deployment and other Quality KPIs.
• In-charge of product Batch release for placement in the market in line with the marketing authorization by cGMP Guidelines (NAFDAC/WHO).
• Manages and ensures the validation/qualification of all plant & quality control equipment, validation processes, cleaning of production equipment, utilities and analytical methods are planned for by liaising with other stakeholders in drawing up a qualification/validation master plan {Q/VMP) and subsequently ensuring that the qualification and validation process are carried out according to the Q/VMP.
• Manages the Quality Control and IPC activities and ensuring that all necessary tests are carried out using validated methods before release of any product.
• Managing and handling of all the investigation of all product related Customer Complaints and manufacturing deviations, proffering solutions, preparation and compilation and review of periodic reports of all complaints according to WHO cGMP guidelines and Quality Management System
• Draft, review, and maintenance of the Company’s quality policy and ensure the cascade to all new and existing staff.
• Preparation, review, and maintenance of the site master file in conjunction with other stakeholders.
• Organizing/carrying out of QMS and GMP related trainings in conjunction with the HR Department.
• Manages the Organization/carrying out of routine self-inspection and preparation of the business for all external audits.
• Management of recall of products, out of specification results and deviations as well as change control affecting quality of products.
• Management of products Stability studies via periodic evaluation of the results of accelerated and follow up stability studies.
• Manages the annual Product quality reviews activities and ensures that annual product quality review and trend analysis is carried out.
• Plan and perform all Quality System Audits in accordance with NAFDAC, WHO cGMP's and other standards as applicable and preparation
• Drafts and manages the budget of the Quality department and ensuring the maintenance of all existing and purchased equipment and materials.
• Ensures that product artworks are well proofread to have the right placement of logo, colour conformances on materials for promotional activities and approval of text and content by Heads of Pharma, Regulatory Affairs and Product Managers respectively before final approval and release.
• Certify that all new products developed meet GMP standards and requirement and play an integral role on all new medicinal products developed by or for Organisation.
• Carry out the duties of Management Representative according to the requirements of Quality Management System guidelines (ISO 9001) and also conducting a biannual Quality management review meeting.
• To ensure in liaison with other stakeholders that rejected or defective materials or products are disposed according to NAFDAC specific rules and regulations.
• To ensure proper documentation, storage, and retrieval of all Quality-related documents according to Organisation guidelines.
• Ensures that all packaging materials are tested/checked as per approved designed and specifications.
• Manages the vendor qualification processes to qualify new suppliers and contract acceptors and re-audit existing contract acceptors.
• To ensure discipline of QA/QC personnel in conjunction with the HR Department.
• To ensure adherence to quality agreement by third party distribution and warehousing partners; and also ensure the monitoring of warehouses and Third-party distribution (e.g. MDS).
• Work closely with the technical director to ensure that the department meets its strategic goal and objectives.
• Manages the Investigation of Deviations, OOS/OOT, Change Control, Reprocessing, Returns, Recalls & proffering CAPA.
• To ensure adequate and effective communication system within and outside the department.

Educational Qualifications / Requirements

• B.Sc. in Biochemistry, Industrial Chemistry, Biological, Pharmaceutical, Physical Sciences and other science related Disciplines.
• Minimum of 10 years work experience.
• Computer literacy and Microsoft Office Proficiency.
• Technical Skills
• Quality Management Skills
• Sound Managerial and People training skills
• High level of integrity, Sound technical knowledge, balanced judgment, and good decision-making skills
• Auditing Skills (Certified Lead Auditor in Systems)
• Equipment Validation and Qualification set of skills and knowledge.
• Process Validation Skills
• Data Analysis, Report Writing and Presentation skills
• CAPA handling and Management Skills
• Problem solving and analytical skills
• The holder must be knowledgeable in Quality Management Systems, Auditing, Good Laboratory Practice (GLP) and Good manufacturing practice (GMP)
• Sound knowledge of data analysis and Monograph interpretation and chromatogram is highly essential.
• Sound knowledge on equipment Management and Validation.
• Complexity: (Provide examples of decisions made and/or problems solved that require analysis data or complex issues)
• The work content is highly technical and calls for high level of integrity and in-depth knowledge of quality management and handling of all quality related complexities.
• Ability to prioritize and act appropriately is essential