Amakuma Nyaku
Wilmington,DE
Summary
I am a graduate with a degree in Pharmaceutical Science and a Certified Pharmacy Technician, with over 14 years pharmaceutical experience in three sectors of the pharmaceutical arena. These sectors include the manufacturing and packaging of drugs, hospital pharmacy and retail pharmacy. This has resulted in me mastering skills including but not limited too: ensuring accurate document review, quality control, quality assurance and an overall deep and broad understanding of the pharmaceutical sector. I am also skilled in collaborating with team members to expedite urgent requests while maintaining impeccable focus on safety, accuracy, and confidentiality. I am an advanced communicator with all levels of staff, clients, management in an organization.
Overview
17
17
years of professional experience
Work History
Quality Assurance Supervisor
Marlex Pharmaceuticals
03.2024 - Current
- Inspect all incoming component shipments to ensure that all applicable specifications are met
- Inspect product shipments coming from contract manufacturers to ensure that all necessary components meet quality standards
- Help trouble-shoot packaging concerns and communicate with contract manufacturers and vendors
- Verifies and inspects incoming materials and works accordingly with Quality Assurance to handle any possible discrepancies
- Participates in other quality audits when required
- Complete and maintain documentation of all items inspected
- Create/review documents, ie. SOPs, batch records as they pertain to the manufacture of each product line
- Performs batch record review and approval, product transfer
- Ensure that all activities are performed according to documented SOPs/batch records
- Assess whether batch record information is complete, accurate, and compliant.
- Identifies quality concerns and escalates to management as appropriate.
- Works as quality representative on cross functional teams to support new product launches
- Participates in the development and maintenance of QA programs, policies, processes, procedures and controls to ensure that products conform to established standards.
- Participates in prioritizing, scheduling and resource allocation in order to maintain efficient workflow.
- Assist with manufacturing floor activities (equipment/room approval, facility compliance)
Specialist Pharmacy Technician
Methodist Le Bonheur
01.2023 - 01.2023
- Aseptic compounding
- Compounding
- Omnicell
- Stock management
- Pharmacy Operations
- Problem solving
- Communication
Production Pharmacist
Aspen Pharmacare
South Africa
08.2011 - 02.2016
- Quality Control
- Documentation Review
- SOPs (Standard Operating Procedures)
- Good Manufacturing Practice guidelines
- Monitoring manufacturing compliance to GMP and statutory requirements
- Checking adherence to guidelines, procedures and document controls
- Delivering expected productivity targets as per business requirements
- Administrative
- Planning and Procedures Planning and prioritizing daily, weekly and monthly activities Determining, requesting and using resources/ assets optimally
- Inspections and Verifications
- Verifying controlled substances
- Verifying certified clean status of rooms and equipment
- Verifying, reviewing, and approving verification of measuring equipment performance, calibrations and sampling, and dispensing of materials
- Line & Production processing Performing, reviewing, and approving line sign-on’s, closures and clearance authorizations Performing, reviewing and approving batch reconciliations to product specifications and quality Ensuring production process adherence to standards and specifications
- Process and system improvements Managing, reviewing, and approving change control programs and deviations/concessions to comply standards and specifications Managing and resolving customer complaints Optimizing processes and identify gaps in policies/procedures CAPA investigations in area of focus
- Compliance & Auditing Performing and reviewing shift GMP checks, environmental checks, and agent expiry dates, and ensuring continued compliance Verifying good document practice as per SOP and regulation Verifying the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity Verifying IPCs (In-process checks) are in line with product quality and specifications Reviewing and approving preliminary batch records Auditing logbooks and systems
- Troubleshooting Investigating deviations and concessions, and assess risk Raising deviations and implement corrective action Raising maintenance notifications as and when required
- Training and technical expertise
- Training new Pharmacists and PMAs(Pharmacist Manufacturing Assistants) on SOPs in transition period
- Identifying refresher or awareness training needs
- Administration & Record keeping
- Completing batch records and labels
- Completing deviation forms as required
- Querying documents and signing off declarations
- Performing and verifying calculations in BMR (Batch Manufacturing Record)
- Maintaining and updating records and systems as required
- Retrieving supporting documentation and records to facilitate and support query resolution
Responsible Pharmacist
Clicks Pharmacy, Umtata & Phezulu Pharmacies
South Africa
01.2009 - 07.2011
- Areas of Expertise obtained in Responsible Pharmacist
- SAPC(South African Pharmacy Council) and relevant legal knowledge
- Ethical working practice and compliance
- Excellent knowledge of stock, cost, risk and compliance management procedures
- Excellent knowledge of patient care, professional counseling
- Excellent handling of customer service
- Knowledge of labor legislation
- Good understanding and application of financial management principles
- Good knowledge of competency-based interviewing
- Managerial, tutorship and coaching skills
- Results and target driven
- Planning and organizing skills
- Problem-solving skills
- Strong customer orientation
- Interpersonal skills (Customer service orientation and effective patient care)
- Computer literacy
Education
US Pharmacy Technician - undefined
Southwest Community College
09.2022
Bachelors of Pharmacy - Pharmaceutical Science
Nelson Mandela Metropolitan University
Port Elizabeth04.2007
Skills
- Problem solving
- Drug Safety
- Pharmaceuticals Operations
- Quality Control
- Quality Assurance
- LEAN manufacturing
- Supervising staff
- Drug manufacturing on large and small scale
- Pharmaceuticals Labeling
- Computer skills
- SOPs
Timeline
Quality Assurance Supervisor
Marlex Pharmaceuticals
03.2024 - Current
Specialist Pharmacy Technician
Methodist Le Bonheur
01.2023 - 01.2023
Production Pharmacist
Aspen Pharmacare
08.2011 - 02.2016
Responsible Pharmacist
Clicks Pharmacy, Umtata & Phezulu Pharmacies
01.2009 - 07.2011
US Pharmacy Technician - undefined
Southwest Community College
Bachelors of Pharmacy - Pharmaceutical Science
Nelson Mandela Metropolitan University