MAXWELL NIMO TETTEH
Leicester,United Kingdom
Summary
Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
12
12
years of professional experience
9
9
years of post-secondary education
Work history
Quality Assurance / Environmental and Safety Manager
Pokupharma Limited
Kumasi, Ghana
2016.01 - 2023.07
- Ensure availability of approved procedures and specifications for reference
- Ensure compliance to National and International regulatory cGMP requirements.
- Review Batch Manufacturing and Testing Records, before giving product release
- Review and Authorize Validation Master Plan, Protocols and provide support for validations.
- Ensure compliance of Change control procedures
- Compiling Finished Product Dossier (CTD) for registration.
- Ensure Induction and training of employees as per the “Induction Manual and Training Guidelines”.
- Ensure compliance of cGMP's through audits
- Carry out Process controls, including in-process checks/ inspections/ line clearances.
- Inspection of final packed stock, before release
- Investigate complaints, deviations, quality incidents and non-conformances.
- Handling of regulatory inspections at the site
- Take actions on Product recalls and investigate the reasons.
- Ensure implementation of amendments in specifications and procedures as per current Pharmacopoeia standards
- Review Product stability reports
- Review Batch Manufacturing, Batch Packing Records, verify reconciliation of batch inputs, batch yields and finally release of finish product.
- Document control and ensure proper archival and fast retrieval of records.
- Ensure cGMP and cGLP training to the staff.
- Evaluation of all contract services providers
- Evaluation and approval of all vendors supplying materials to Pokupharma Limited
- Conduct site inspections to identify environmental hazards and make recommendations for corrective action.
- Maintaining records of environmental data during monitoring.
- Preparing Environmental Management Plan (EMP)
- Preparing and submission environmental reports (QER and AER) to the Environmental Protection Agency.
Asst Quality Control Manager
Pokupharma Limited
Kumasi, Ghana
2011.10 - 2015.12
- Supervise in-process quality control during production.
- Carry out quantitative and qualitative analysis on raw material and finished product.
- Carry out analysis on Purified water for production.
- Develop and review standard operating procedure for approval.
- Carry out stability studies for Finished Pharmaceutical Products.
- Assist in analytical method validation.
- Attended meetings and submitted decisions made to senior management for approval.
Regulatory Officer II
Food and Drugs Authority
Accra, Ghana
2009.09 - 2011.08
- Received samples and Product dossier from clients for drug registration.
- Data entry for drug registration application
- Prepared samples for laboratory analysis
- Evaluated primary and secondary package of finished submitted for registration.
- Maintained the samples and Dossier room.
- Assist in dossier evaluation meeting.
- Reported audit results to identify and evaluate opportunities for improvement.
National Service Person
Food and Drugs Authority
Accra, Ghana
2008.10 - 2009.09
- Updated of samples and dossier into various drug registration application book
- Prepared samples for laboratory analysis
- Evaluating of primary and secondary package of drugs
- Maintained the samples and dossier room.
- Supported in organizing dossier evaluation meeting.
- Supported in monitoring radio and television adverts on pharmaceutical products.
- Built constructive relationships with staff and customers for positive, productive workplace environments.
Education
BSc - Chemical Engineering
Kwame Nkrumah University of Science and Technology
Kumsi 2004.08 - 2008.05
Senior Secondary School Certificate - Science
Ghana Senior High School
Ghana 2000.06 - 2002.08
Basic Education Certificate Examination -
Goshen Educational Complex
Accra 1997.01 - 1999.09
Skills
- KEY COMPETENCES
- Excellent interpersonal communication skills, strong attention to details, organizational and leadership skills and ability to work in a team Clear understanding of Quality Management System and cGMP
- Good computing skills:
- Microsoft Word
- PowerPoint
- Excel and
- Internet Skills
Languages
English
Native
Timeline
Quality Assurance / Environmental and Safety Manager
Pokupharma Limited
2016.01 - 2023.07
Asst Quality Control Manager
Pokupharma Limited
2011.10 - 2015.12
Regulatory Officer II
Food and Drugs Authority
2009.09 - 2011.08
National Service Person
Food and Drugs Authority
2008.10 - 2009.09
BSc - Chemical Engineering
Kwame Nkrumah University of Science and Technology
2004.08 - 2008.05
Senior Secondary School Certificate - Science
Ghana Senior High School
2000.06 - 2002.08
Basic Education Certificate Examination -
Goshen Educational Complex
1997.01 - 1999.09