ROLES AND EXPECTATIONS
- Schedule and prepare protocols/reports and conduct process and cleaning validation.
- Provide ongoing training, motivation, coaching, support, and correction to employees to ensure that quality standards are met.
- Responsible for investigation of deviations, complaints, and recalls in coordination with RA.
- Issue controlled documents, e.g. specifications, BMRS, BPRs, preventive maintenance, facility layouts, SOPs, protocols, etc.
- Collect and compile statistical quality data, keeping accurate record of the same (APQR)
- Monitor cleaning of warehouses, temperature mapping, and recording.
- Support the quality assurance team leaders to ensure the development of fit-for-purpose QA policies and procedures and monitor the implementation and effectiveness of the same.
- Document and report quality issues to management and other departments.
- Verify the received materials on receipt and ensure that it adheres to the accepted quality limits.
- Carry out online inspections of documents for compliance to data integrity.
- Be responsible for the retention, issuance and destruction of all records.
- To follow up on the approved reprocessing and reworks
- To follow up on the Approved Change controls, CAPA, Risk
- To ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to the need.
- Online documentation; log books, reports and BMRs.
AUTHORITIES
- Issuing controlled documents.
- Deviation reporting on non-conforming activities.
- Line clearance for all production activities.
COMPETENCIES
Technical Knowledge/Skills:
- Report Writing Skills
- Influencing Skills
- Budget management skills
- Analytical Skills
- Presentation skills
- Good communication & interpersonal Skills
- Computer Skills (PPt, Excel and MS Word)
- Negotiation skills
- Strategic thinking
- Conflict Management
- Able to learn and adapt to change.
- Innovative/creative skills.
- Intermediate level of English and one other local language, preferably Luganda.
Behavioral/Attitude Competencies:
- Respect for others
- Sociable
- Leadership
- Result oriented
- Open and Decisive.
- Business Acumen
- Teamwork
- Responsible
- Mature & assertive
TRAINING REQUIREMENTS:
- Basic safety training
- Basic GMP training
- Good documentation practices training
MINIMUM QUALIFICATIONS/REQUIREMENTS:
- Degree in chemistry, pharmacy, or a related field.
- A relevant postgraduate qualification is an added advantage.
- 2 years of experience preferably in a pharmaceutical/healthcare industry