4 Stability Chamber Operator
2025-05-09T09:08:29+00:00
Dei BioPharma
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https://deibiopharma.com/
FULL_TIME
Matugga
Uganda
00256
Uganda
Healthcare
Healthcare
2025-05-12T17:00:00+00:00
Uganda
8
Job Summary:
The Stability Chamber Operator is responsible for managing the storage and monitoring of pharmaceutical samples under controlled environmental conditions as part of stability studies in compliance with ICH guidelines (Q1A–Q1F), Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMP). The role includes sample labeling, placement, withdrawal, documentation and maintenance of inventory for both long-term and accelerated stability studies. The operator will be responsible for ensuring the proper functioning of stability chambers, including temperature and humidity monitoring, alarm response and equipment calibration coordination. The ideal candidate should have experience in stability operations, strong organizational skills and a working knowledge of regulatory and documentation standards applicable to pharmaceutical stability programs.
Key Duties and Responsibilities:
- Operate and monitor stability chambers in compliance with ICH guidelines (Q1A(R2)) and internal SOPs.
- Perform regular checks on temperature, humidity and other environmental parameters to ensure chamber conditions remain within validated ranges.
- Schedule and organize stability pulls based on predefined protocols and study designs.
- Label and place stability samples in appropriate conditions ensuring traceability and documentation.
- Conduct preliminary visual inspections of samples at stability intervals and submit them to the analytical lab for further testing.
- Maintain accurate and up-to-date records of chamber usage, sample log-ins and environmental deviations.
- Perform routine preventive maintenance and initiate service requests for stability chambers as necessary.
- Participate in the qualification and requalification of chambers including temperature/humidity mapping.
- Support audit readiness by ensuring all stability documentation is accurate, traceable and compliant.
- Collaborate with QC, QA and Product Development teams to ensure the effective execution of stability programs.
Academic Qualifications:
Diploma or Bachelor’s degree in Pharmaceutical Sciences, Industrial Chemistry, Laboratory Technology or a related scientific field from a recognized institution.
Experience and Competencies:
- Minimum of 2–4 years of relevant experience in a pharmaceutical or regulated manufacturing environment.
- Demonstrated experience working with controlled environmental chambers (stability or incubation) and understanding of ICH stability requirements.
- Familiarity with GDP, cGMP, and basic laboratory operations related to sample handling and documentation.
- Ability to read and interpret temperature/humidity monitoring charts, and to respond appropriately to deviations.
- Basic understanding of Good Laboratory Practices (GLP) and internal documentation control systems.
- Attention to detail, reliability, and the ability to work independently with minimal supervision.
- Prior experience supporting audits and inspections will be an added advantage.
Operate and monitor stability chambers in compliance with ICH guidelines (Q1A(R2)) and internal SOPs. Perform regular checks on temperature, humidity and other environmental parameters to ensure chamber conditions remain within validated ranges. Schedule and organize stability pulls based on predefined protocols and study designs. Label and place stability samples in appropriate conditions ensuring traceability and documentation. Conduct preliminary visual inspections of samples at stability intervals and submit them to the analytical lab for further testing. Maintain accurate and up-to-date records of chamber usage, sample log-ins and environmental deviations. Perform routine preventive maintenance and initiate service requests for stability chambers as necessary. Participate in the qualification and requalification of chambers including temperature/humidity mapping. Support audit readiness by ensuring all stability documentation is accurate, traceable and compliant. Collaborate with QC, QA and Product Development teams to ensure the effective execution of stability programs.
Diploma or Bachelor’s degree in Pharmaceutical Sciences, Industrial Chemistry, Laboratory Technology or a related scientific field from a recognized institution. Experience and Competencies: Minimum of 2–4 years of relevant experience in a pharmaceutical or regulated manufacturing environment. Demonstrated experience working with controlled environmental chambers (stability or incubation) and understanding of ICH stability requirements. Familiarity with GDP, cGMP, and basic laboratory operations related to sample handling and documentation. Ability to read and interpret temperature/humidity monitoring charts, and to respond appropriately to deviations. Basic understanding of Good Laboratory Practices (GLP) and internal documentation control systems. Attention to detail, reliability, and the ability to work independently with minimal supervision. Prior experience supporting audits and inspections will be an added advantage.
JOB-681dc60d0fe56
Vacancy title:
4 Stability Chamber Operator
[Type: FULL_TIME, Industry: Healthcare, Category: Healthcare]
Jobs at:
Dei BioPharma
Deadline of this Job:
Monday, May 12 2025
Duty Station:
Matugga | Uganda | Uganda
Summary
Date Posted: Friday, May 9 2025, Base Salary: Not Disclosed
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JOB DETAILS:
Job Summary:
The Stability Chamber Operator is responsible for managing the storage and monitoring of pharmaceutical samples under controlled environmental conditions as part of stability studies in compliance with ICH guidelines (Q1A–Q1F), Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMP). The role includes sample labeling, placement, withdrawal, documentation and maintenance of inventory for both long-term and accelerated stability studies. The operator will be responsible for ensuring the proper functioning of stability chambers, including temperature and humidity monitoring, alarm response and equipment calibration coordination. The ideal candidate should have experience in stability operations, strong organizational skills and a working knowledge of regulatory and documentation standards applicable to pharmaceutical stability programs.
Key Duties and Responsibilities:
- Operate and monitor stability chambers in compliance with ICH guidelines (Q1A(R2)) and internal SOPs.
- Perform regular checks on temperature, humidity and other environmental parameters to ensure chamber conditions remain within validated ranges.
- Schedule and organize stability pulls based on predefined protocols and study designs.
- Label and place stability samples in appropriate conditions ensuring traceability and documentation.
- Conduct preliminary visual inspections of samples at stability intervals and submit them to the analytical lab for further testing.
- Maintain accurate and up-to-date records of chamber usage, sample log-ins and environmental deviations.
- Perform routine preventive maintenance and initiate service requests for stability chambers as necessary.
- Participate in the qualification and requalification of chambers including temperature/humidity mapping.
- Support audit readiness by ensuring all stability documentation is accurate, traceable and compliant.
- Collaborate with QC, QA and Product Development teams to ensure the effective execution of stability programs.
Academic Qualifications:
Diploma or Bachelor’s degree in Pharmaceutical Sciences, Industrial Chemistry, Laboratory Technology or a related scientific field from a recognized institution.
Experience and Competencies:
- Minimum of 2–4 years of relevant experience in a pharmaceutical or regulated manufacturing environment.
- Demonstrated experience working with controlled environmental chambers (stability or incubation) and understanding of ICH stability requirements.
- Familiarity with GDP, cGMP, and basic laboratory operations related to sample handling and documentation.
- Ability to read and interpret temperature/humidity monitoring charts, and to respond appropriately to deviations.
- Basic understanding of Good Laboratory Practices (GLP) and internal documentation control systems.
- Attention to detail, reliability, and the ability to work independently with minimal supervision.
- Prior experience supporting audits and inspections will be an added advantage.
Work Hours: 8
Experience in Months: 24
Level of Education: associate degree
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