Organisation: Dei BioPharma Ltd
Duty Station: Matugga, Wakiso, Uganda
About the Company:
Dei BioPharma Ltd is a biotech and pharmaceutical research firm duly incorporated in Uganda, specializing in the development and manufacture of innovative medicines and vaccines. Our state-of-the-art manufacturing facility, situated in Matugga, Wakiso district, Uganda, shall produce high-quality medicines across a wide range of therapeutic areas.
Job Summary: Dei BioPharma Ltd., a Drugs and Vaccines Manufacturing Plant is seeking eligible and qualified applicants for the position of Quality Assurance Officer. The candidate will be responsible for implementing the Quality Management Systems at the shop floor and to ensure that Change requests, Deviation & Failure Investigations, Product Complaints, Quality Risks and CAPA are efficiently & timely managed as per the cGMP requirements.
Key Duties and Responsibilities:
- Log in, investigate and close all event and deviations within allocated timelines as per approved procedure and issue the final report after getting signed off.
- Log in, review the proposed change requests, get evaluated from relevant stake holders, and monitor the progress on implementation and close them as per approved procedure.
- Log in, review the identified potential risks, evaluate and assess them for criticality and suggest mitigation plan get authorized it, monitor the implementation of action plan and close as per approved procedure.
- Log in, define action items, responsibilities and timelines, get approved and close all initiated CAPA on approved format and in accordance with the approved procedure.
- Log in, investigate and close all reported product technical complaints on approved format, in accordance with the approved procedure.
- Maintenance and retention of all records related to Quality Systems.
- To participate in the internal audit of the facility in the capacity of lead or assist auditor.
- Develop and report the monthly KPIs of event & deviation, Change control, CAPA and product technical complaint on monthly basis.
Qualifications, Skills and Experience:
Education:
- Bachelor’s degree in Pharmaceutical Sciences.
- An advanced Degree (master’s) in a relevant field is an advantage but not required.
Experience:
- 3-5 years of experience in a reputable pharmaceutical quality assurance function, and have a hands on experience of handling of QMS relevant documentation and processes.
Job knowledge:
- Understanding of quality standards and regulatory requirements specific to the pharmaceutical quality management system. Ability to apply regulatory knowledge to ensure the compliance in all QMS documentation & processes.
- Language: English level IV (Advanced knowledge) Reading/Writing/Speaking is required.
Skills and abilities:
- Proficiency in Quality Assurance System and procedures.
- Knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) with regulatory guidelines from agencies such as the FDA, EMA, or WHO.
- Regulatory Knowledge
- Analytical and Problem-Solving Skills
- Software Proficiency (like, MS Office)
- Attention to Details
- Organizational Skills
- Continuous Learning
Qualifications: All applicants under consideration will be required to pass medical and security certifications.
EQUAL OPPORTUNITY EMPLOYER: Dei BioPharma Ltd. provides equal opportunity and fair and equitable treatment in employment to all people without regard to race, color, religion, sex, national origin, age, disability, political affiliation, marital status, or sexual orientation.
How to Apply:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Head Human Capital)
All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB
Applications should be sent by email to [email protected] with the
JOB TITLE IN THE SUBJECT LINE.
Deadline: 21st October 2024 by 5:00PM
NB: Should you not hear from us within fourteen (14) days from the closing date of this advertisement, you may consider your application to be unsuccessful.
