Fredrick Manyala Email and Phone Number
Detailed-Oriented Quality Assurance enthusiast with superb problem-solving and analytical abilities. Meticulous in record keeping and documentation as regards the WHO-ICH cGMP standards. Specialties include regulatory compliance, operational improvements, program implementation, documentation, and process validation. Eager to contribute toward team success through hard work, attention to detail, and excellent organizational skills. Self-motivated to learn, grow and excel in the pharmaceutical industry.
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Quality Assurance ManagerSphinx Pharmaceuticals LtdNairobi County, Kenya -
Quality Assurance ManagerSphinx Pharmaceuticals Ltd Apr 2022 - PresentNairobi, Kenya•Enhancing training activities at Sphinx Pharmaceuticals Limited for all GMP and GDP-related activities by defining, planning, and supporting training activities.•Ensure compliance to manufacturing and testing activities with respect to applicable domestic and international and other regulatory cGMP expectations and requirements, industry guidelines, and to Sphinx Pharmaceuticals Limited QMS and SOPs•Resolve moderately complex quality events and issues (e.g., deviations, investigations, Out-of-Specification / Out-of-Trend investigations, or any other quality events related to the manufacture of finished pharmaceutical products)•Review and provide input (e.g., failure analysis, problem-solving, and risk assessment and mitigation) for quality activities and events related to the manufacture or testing of finished pharmaceutical product •Develop, implement, and deploy enhancements to Sphinx Pharmaceuticals Limited Quality System procedures•Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to Sphinx Pharmaceuticals Limited Quality Manual - maintain an annual auditing program, participate in audits, manage action plans and follow up on agreed-upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate. Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.•Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality-related matters is provided to the company. Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors), and Global Quality Assurance. •Supporting and enhancing Good Warehousing Practices and Good Distribution Practices within Sphinx Pharmaceuticals limited in line with WHO-ICH recommendations. -
Head Of Quality Assurance, Head Of Regulatory Affairs, Warehouse Manager.Inspire Pharmaceuticals Limited Nov 2021 - Mar 2022Nairobi, Kenya• Preparation of product dossiers for registration of products with the PPB.• Co-ordination of clinical presentations and meetings with Private Sector Hospitals, County Hospitals and National Referral Hospitals• Co-ordination of importation of drugs• Liaising with bodies such as the Pharmacy and Poisons Board (PPB), Pharmaceutical Society of Kenya (PSK) and Hospital Pharmacists Association of Kenya (HOPAK) to further the growth of Inspire Pharmaceuticals Ltd in the region.• Liaising with multilateral and Development Agencies such as World Health Organization (WHO), Ministry of Health (MOH), County Governments Health Departments, NGOs and Faith Based organizations (MEDS) on medical and pharmaceutical matters.• Maintenance of the warehouse in a clean and orderly manner, ensuring that infection control measures are followed at all times, maintaining a high level of cleanliness and monitoring temperature/humidity on daily basis.• Management of the stock management documentation including proper use of bin cards, stock cards, waybills and registers.• Ensure that the condition and expiry dates of drugs and medical supply ordered are properly checked.• Ensure that all medications are stored in the correct manner using principles of FIFO/FEFO to ensure high quality of medications and safety of patients.• Receive, Store and organize for deliveries of the pharmaceutical products to clientswith relevant documentation.• Conduct monthly physical stock counts and prepare the Monthly stock reports for Inspire Pharmaceuticals Management.• Provide quarterly stock consumption reports to the Management• Report all issues of stock rupture and expiry drugs to the Management.• Ensure all stocks are accounted for and reports are accurate.• Ensure warehouse temperatures are properly maintained, and the cold chain storage system is adhered to as per good distribution practices (GDP)
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Quality Assurance OfficerSphinx Pharmaceuticals Ltd Jun 2021 - Nov 2021Nairobi, KenyaAnnual Product Quality Review for all Sphinx Pharmaceuticals limited product lines Ensure the retention of all the registered products with the regulatory authority (PPB) Development and design of an electronic Common Technical Document (Dossier) for submission to PPB for the registration of new products of Sphinx Pharmaceuticals Limited Validation and Qualification of equipment, processes and procedures, premises as per the Validation and Qualification protocols Supervising and authorization of all In Process Quality Assurance activities within Sphinx Pharmaceuticals Limited Maintaining the Register for all the batches of products manufactured by Sphinx Pharmaceuticals Limited Custodian of all the Sphinx Pharmaceuticals Limited Quality Assurance and GMP documents Training and evaluation of the relevant personnel on the various Standard Operating Procedures Review and authorization of sphinx Pharmaceuticals Limited Standard Operating Procedures Handling of drug recalls and market complaints as per the relevant standard operating procedures Carry out periodic planned internal audits followed by step-by-step Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) measures -
PharmacistBeleview South Hospital May 2020 - Apr 2021South C, Nairobi• Chairperson of the Infection Prevention and Control (IPC) committee • Attending major ward rounds hence providing critical pharmaceutical information to the clinicians and doctors • Development and implementation of the pharmacy budget • Development and implementation of cost control measures • Development of key policies, procedures, and protocols for the pharmacy staff • Timely evaluation of pharmacy staff, including performing annual reviews for direct reports • Development and implementation of quality improvement projects in the pharmacy department • Creating, maintaining, updating, and enforcement of the lean pharmacy standards in the pharmacy workflow • Supervising and coaching of pharmacy staff including orientation of new staff
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PharmacistTouchstone Pharmacy Sep 2019 - Apr 2020Nairobi, Kenya• Recommending OTC medication options to help mitigate individual symptoms.• Protecting drug inventories from damage or theft by establishing and enforcing clear pharmacy policies.• Educating patients on possible drug interactions, potential side effects and optimal methods of administration.• Performing blood pressure and blood glucose tests on patients and further giving informed counselling based on the test results.
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PharmacistSyokichem Pharmaceuticals Mar 2019 - Sep 2019
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PharmacistHost Pharmacy Feb 2019 - May 2019Nairobi Kenya
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PharmacistCooper K-Brands Limited Nov 2018 - Jan 2019Nairobi Kenya -
PharmacistJaramogi Oginga Odinga Teaching And Referral Hospital (Jootrh) May 2018 - Oct 2018Kisumu Kenya
Fredrick Manyala Skills
Fredrick Manyala Education Details
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Pharmacy
Frequently Asked Questions about Fredrick Manyala
What company does Fredrick Manyala work for?
Fredrick Manyala works for Sphinx Pharmaceuticals Ltd
What is Fredrick Manyala's role at the current company?
Fredrick Manyala's current role is Quality Assurance Manager.
What schools did Fredrick Manyala attend?
Fredrick Manyala attended University Of Nairobi.
What skills is Fredrick Manyala known for?
Fredrick Manyala has skills like Community Pharmacy, Process Validation, Writing, Microsoft Office, Pharmacy, Planning, Process Improvement, Dossier Preparation, Medication Therapy Management, Pharmacology, Pharmacovigilance.
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FREDRICK MANYALA
Dar Es-Salaam
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