Registered pharmacist

CURRICULUM VITAE

Name: Branice Mmboga Igambi

Email: *********@*****.***

Phone no.: 071*******

PERSONAL SUMMARY

I am a registered pharmacist, with four years of professional experience; three and a half years in a pharmaceutical industry in both Quality Assurance and Regulatory Affairs department and half a year in a hospital setup.

I have strong work ethics, with a high level of integrity and moral standards, great communication skills with fluency in both written and spoken English and Kiswahili. I also have excellent organizational and time management skills as well as great customer relations. Am currently working in Universal Corporation Limited (a WHO prequalified company) as a Regulatory Affairs Executive preparing product registration dossiers, filing variations, replying to queries and any other general regulatory concern pertaining to the quality of our products. In this sector, I have gained experience in regulatory compliance, current Good Manufacturing Practices, Quality Management Systems and quality adherence in product manufacturing and subsequent release. The roles in this sector enabled me to develop a valuable and transferable skill set which stands me in good stead for the vacancy of Quality Assurance/Regulatory Affairs Pharmacist.

SKILLS AND STRENGTHS

• Strong work ethics – I display a high level of integrity and moral standards during my work and in relating to the clients

• Communication skills – excellent interpersonal, networking, presentation, persuasion, influencing, negotiation and closing skills. Works effectively in a collaborative environment.

• Strong organization and time management skills

• Strategic and analytical thinking, multitasking and prioritization.

• Good team player – I interact well and easily with colleagues and provide a friendly space for work.

WORKEXPERIENCE

January 2020 – present: Universal Corporation Limited, Regulatory Affairs Department. My duties here entail:

1. Compilation of registration dossiers.

2. Ensure maintenance and update of registrations in accordance with the relevant legislations, regulations and guidelines.

3. File variations with the Pharmacy and Poisons Board in case of any changes in the registered products.

4. Monitoring Regulatory changes affecting quality and compliance of our products 5. Submitting answers to queries raised in the process of registration. 6. Determine and communicate drug approval requirements 7. Compile and maintain regulatory documentation databases. 8. Interpret regulatory rules or changes and ensure that they are implemented as per Guidelines.

9. Provide technical review of data or reports that will be incorporated into regulatory submissions to ensure scientific accuracy and clarity of presentation 10. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements or clarification and follow-up of submissions under review.

11. Review of Product Quality review documents for correctness and compliance to the relevant SOPs

12. Participating in training and understanding of SOPs and other learning platforms. October 2017-December 2019: Universal Corporation Limited, Quality Assurance Department My duties in this department entailed:

1. Ensure that medicinal products are released into the market after certification by the qualified person.

2. Ensuring deviations during manufacture are investigated, root causes found, CAPAs undertaken to avoid potential deviations from recurring. 3. Review of Risk Assessments, deviations and Out of Specifications documents attached to the Batch Manufacturing Records to ensure no impact on product quality before release.

4. Evaluate planned changes and their approval prior to implementation, taking into account regulatory notification and approval where required through change control management.

5. Ensure that all the necessary controls on intermediate products and any other in process controls and validations are carried out.

6. Ensure that medicinal products are handled and stored properly so as to maintain their quality throughout their shelf life.

7. Reviewing of the Batch Manufacturing Records to audit methods, results, systems and procedures followed during the manufacturing process. 8. Manage data integrity by reviewing documentation to ascertain compliance to relevant SOPs, identifying error and implementing corrective action. 9. Reject batches that have failed the standard tests and recommend for destruction of such batches.

10. Ensuring the drug manufacturing process adheres to GMP requirements to ensure quality of the end product.

11. Perform the tasks assigned on QMS, affecting batches in production. March 2017 – September 2017: Lifeline group of hospitals, Membley

• Checking prescriptions to ensure their accuracy before dispensing.

• Dispensing drugs to patients as per the prescriptions

• Properly packaging and labelling of medicine

• Referring patients to the physician in case of recurrent illness

• Offering consultation on minor ailments

• Issuing over the counter medicine

• Procured stock for the pharmacy

• Entered data on medicine received into the data base to facilitate tracking and accountability

• Participated in training programs.

• Ensured proper handling and storage of medicine in the pharmacy

• Conducted stock take and reconciled invoices with physical stock to check for discrepancies

• Received medicine and verified expiry dates and the information on invoices against products delivered

• Ensured there was adequate stock of medicine in the pharmacy

• Provided information to management on the status of inventory

• Ensured there was a good filing system for documents such as invoices December 2016 – February 2017: Biodeal Pharmaceutical Industry I did a three-month internship at Biodeal Pharmaceutical industry in both the quality assurance and quality control departments.

Duties

• Ensuring processes are carried out as per current GMP requirements.

• Ensuring staff is properly gowned as stipulated in the SOP.

• Carry out in-process tests during the manufacturing process

• Ensuring data integrity is observed throughout the process of data collection and recording.

• Learning the various tests carried out in the Laboratory on both the raw materials and Finished Pharmaceutical Products.

• Reception of raw materials into the warehouse, storage and retrieval, as well as dispatch of the finished pharmaceutical products.

September 2016 – November 2016 Goodlife Pharmacy, Greenspan I worked as an intern at Goodlife Greenspan branch for 3 months with the following key responsibilities:

• Receiving clients by greeting them and enlightening them on services offered.

• Giving private consultation where required

• Carrying out blood sugar, blood pressure and malaria tests

• Issuing over the counter drugs to patients correctly, giving instructions on dosing frequency as well as conditions of taking the drugs and what to avoid in the course of treatment

• Doing follow up on the patient to check on their prognosis

• Accurately dispensing drugs as per the doctor’s prescription.

• Checking inventory and preparing orders.

• Ensuring the premises was clean.

• Prepared reports for accounting purposes

• Took part in stock taking to reconcile physical stock with the data base figures

• Received drugs and verified them against invoices

• Entered data on medicine received into the database for tracking and accountability

• Ensure proper handling and storage of drugs

February 2016 – August 2016: Tigoni Level IV Hospital. I worked here as a pharmacist intern for 6 months. Key responsibilities included:

• Accurately dispensing drugs to the patients as per the doctor’s prescription

• Checking prescriptions for errors

• Measuring, packaging, labelling and recording of medicine to be issued to patients

• Instructing patients on how to use the medicine, their possible side effects and appropriate storage conditions

• Dispensing drugs from the pharmacy to the wards and other departments in the hospital.

• Ensure dispatch of drugs to other health care facilities in the region (applies to ARVs) is done in a timely manner

• Receiving deliveries and verifying them against invoices

• Updating inventory management tools such as bin cards

• Maintain records of narcotic drugs and ensure safe keeping of controlled substances. EDUCATIONAL BACKGROUND

a) University: Mount Kenya University

Bachelor of Pharmacy

b) College: Thika Institute of Business Studies

Diploma in sales and Marketing

c) High School: Bunyore Girls’ High School

Grade B+

REFEREES

Dr. Muriithi George

Former Regulatory Affairs Manager, Universal Corporation Limited Phone no.: 072*******

Dr. Dharmesh Patel

Quality Assurance Manager, Universal Corporation Limited Phone no. 078*******

Dr. Jennifer Muthoni

Pharmacist in charge, Tigoni Level 4 Hospital

Phone no: 072*******

Dr. Onkoba Eric

Quality Assurance Manager, Novo Nordisk

Phone no: 072*******

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