Highlights:

Skills:analytical chemist, project leader, chemist, quality assurance, quality control, microsoft office, seo, as400, lims, Leadership, Organizational and planning, Communication, Problem-solving, Statistical analysis, Industry-specific technical knowledge, UHPLC, Chromatography, Critical thinking, Six Sigma, iso 9001, Agilent LabSolutions, Empower 3, Azura, Shimadzu, Waters

Regulations and New Business Development Analyst 08/2020 - current
Datlabs Pvt Ltd, Bulawayo, Matebeleland Zimbabwe
Industry: Pharmaceutical Manufacturing
• Regulatory Affairs • New Product Development • Product Failure and Complaints investigations, CAPA • Validation and Qualification • Analytical Method Development • Product Packaging Development and Approval • Research Techniques Implement in investigations and new product formula development. • QMS, cGMP Enforcement, Audit and Training Activities
•Design and set specifications of production scale processes and validation thereof. •Liase with packaging service providers on designs and supply; and approve release of primary and secondary packaging •Co-develop production plans for larger scale projects. •Review and define research and/or product development requirements with Supervisor. •Develop product constructions and processes, including all experimentation/evaluation and specifications assembly. •Design, validate & conduct analytical procedures for new and prospective pharmaceutical products and active product ingredients. •Analyse and review technical data from analytical tests and property testing to make conclusions. •Define test methodologies and requirements. Prepares test samples and conduct tests on chemicals and/or materials as required to support programs •Draft, review and maintain report documentation on laboratory analyses, batch manufacturing records, regulatory forms and other QA-controlled documentations. •Investigate out of specification, customer complaints, and nonconformities with associates from other departments as needed (e.g. cross-functional teams). •Support the development of appropriate Corrective and Preventative Actions (CAPAs), risk-assessments, gap analyses and continuous improvement activities. •Interface with customers on new product applications.. •Arrange and develop annual training programs. •Performs all duties consistent with established guidelines consistent with ISO-9001 and those elements of cGMP including audit activities as outlined in the Quality Manual. • Compile, perform and review the validation of analytical methods, manufacturing processes and; equipment qualification of manufacturing and analytical machinery--
QA/QC and Validation Analyst 01/2017 - 08/2020
CAPS Pvt Ltd, Harare, Harare Zimbabwe
Industry: Pharmaceutical Manufacturing
• Internal and External GMP Audits. • Regulatory Affairs • Quality Control Analyses of Raw materials and Finished Products • Manufacturing and Analytical equipment qualification • Analytical Method development and Validation • Manufacturing process validation • Protocol, Reports and SOP Compilation • Laboratory Management
• Commissioning and qualification of the Beta Lactam manufacturing plant. •Assisted the QA manager in monitoring change management associated with validated processes, quality control, quality systems and continuous improvement efforts and managing regulatory affairs and the QA associated responsibilities stated below. •Complied SOPs, work instructions, batch records and protocols for validation and qualification •Registration and reformulation of pharmaceutical products and managing applications for registration certificates from national authoritative agencies. •Executed and managed laboratory and manufacturing activities’ compliance to GMP, ISO, regulatory requirements and global harmonization initiatives. •Monitored and controlled organizational intellectual property i.e. product dossiers and registration certificates. •Assisting in preparation of product license documentation, investigation reports, summaries and reviews •Develop and lead training activities for both laboratory and QMS principles for quality assurance staff. •Tracked and monitored change controls, out of specification and noncompliance investigations of the laboratory and manufacturing departments. •Coordinated and executed internal and external GMP audits and; development of appropriate Corrective and Preventative Actions (CAPAs) and continuous improvement activities. •Compilation and conducting validation and qualification protocols for analytical methods, manufacturing processes, manufacturing and analytical equipment •Compiled analytical and batch manufacturing records and performed quality control analyses on raw materials and finished products. •Developed and validated new analytical methods. •Performed calibration of laboratory equipment, troubleshooting, managing laboratory inventory, writing of SOPs for the department--
ZJC Science Teacher 01/2016 - 12/2016
Zengeza 2 High School, Harare, Harare Zimbabwe
Industry: Education
Extracurricular Dance Training Lecturing Learning progress assessment Examination
Developing student progress schemes •Developing and managing lesson plans and tracking students' learning progress •Delivering learning content/lecturing--
Production Engineer Intern 07/2013 - 08/2014
Nash Paints Pvt Ltd, Harare, Harare Zimbabwe
Industry: Chemical Manufacturing
• Quality Control Analyses of Raw materials and Finished Products • Manufacturing and Analytical equipment qualification • Protocol, Reports and SOP Compilation • Laboratory Management • Quality Assurance and Control Management Systems
•Quality Assurance and Control Management Systems execution, •Product Quality tests: Hold time studies, finished products and in process checks, •Perform GMP compliance monitoring and review for continuous improvement, •Occupational and Health Safety Consulting, •Assist in product nonconformities and out of specification investigation, •Perform production equipment qualification and validation. •Conduct laboratory management and equipment maintenance, •Preparation of laboratory and production reports, •Manage product packaging and labelling.--

Bindura University of Science and Technology 08/2011 - 08/2015
Bindura, Mashonaland Central, Zimbabwe
Degree: Bachelor's Degree
Major:Chemical Technology
Analytical chemistry Inorganic Chemistry Organic Chemistry Physical Chemistry Laboratory Techniques Polymer Chemistry Industrial Chemistry Mineral processing Material Chemistry Mathematics Physics Quality Management systems Medicinal Chemistry Plastic technology Forensic technology Mineral Technology Agrochemistry

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Sharon W Manyanye CV 2024 Quality Control Assurance