JOB DETAILS:
ROLE SUMMARY:
The Quality Assurance Supervisor plays a crucial role in supporting the Quality Assurance Manager in maintaining product quality, safety, and compliance with regulatory requirements. They are responsible for overseeing day-to-day quality assurance activities, conducting inspections and the effective implementation of the pharmaceutical quality system (PQS).

KEY RESPONSIBILITIES:
KRA 1: Inspection and Quality Control:
• Conduct regular inspections of manufacturing processes, equipment, and facilities to ensure compliance with quality standards and cGMP requirements.
• Review batch records, test results, and other quality-related documentation for accuracy and completeness.

KRA 2: Non-Conformance Management:
• Conduct thorough investigations and propose relevant resolutions of nonconformances, deviations, and out-of-specification results.
• Collaborate with the cross-functional team to implement appropriate corrective and preventive actions (CAPAs) to prevent recurrence.

KRA 3: Document Control:
• Development and implementation of Quality Assurance Standard Operating Procedures (SOPs), validation protocols, etc.
• Ensure proper issuance, retrieval, and storage of quality-related documents in the organization.

• Support the maintenance and control of quality-related documents, including Standard Operating Procedures (SOPs), records, and validation protocols.
• Ensure that documentation complies with data integrity and version control requirements.

KRA 4: Training and Development:
• Provide training and guidance to personnel on quality procedures and compliance with cGMP standards.
• Assist in developing training materials and conducting training sessions as needed.

KRA 5: Audits and Inspections.
• Participate in internal and external audits, assisting in the preparation and response to audit findings.
• Collaborate with the cross-functional team to address audit observations and implement necessary improvements.

KRA 6: Continuous Improvement:
• Identify opportunities for process improvements and efficiency enhancements in quality assurance activities.
• Work with cross-functional teams to implement best practices and quality enhancements.

KRA 7: Batch Release:
• Execute the batch release process, ensuring that the finished products meet all quality specifications before release for distribution.

KRA 8: Regulatory Compliance:
• Support the Quality Assurance Manager in ensuring compliance with the local regulatory requirements, including NDA, EAC and other regulatory bodies.

KRA 9: Supplier Quality Management:
• Collaborate with the procurement team to perform supplier audits and evaluations to ensure the quality of raw and packaging materials.

KRA 10: Safety and Compliance Culture:
• Promote a culture of safety, quality, and compliance within the manufacturing plant.

KRA 11: Qualification, validation, verification, and shopfloor activities:

• Plan, support, execute and document all planned and unplanned qualifications, validations, and verifications in coordination with cross-functional team.

• Perform in-process quality control tests and other activities required of QA in Manufacturing, Warehouse, Quality Control and Engineering departments.

Education and Professional Requirements:
The Minimum education level required to perform this job:
• Bachelor’s degree in pharmacy and duly registered with the Pharmaceutical Society of Uganda is a priority.

Total Minimum No. of Years’ Experience Required:
• At least 3 years of relevant experience in a quality-related role within the pharmaceutical manufacturing industry with 1-year in a supervisory role.

ADDITIONAL ROLE INFORMATION:
Additional Skills / Competencies:
• Knowledge of cGMP guidelines, WHO & NDA regulations and other relevant international quality standards.
• Leadership and supervisory skills.
• Excellent analytical and problem-solving abilities to address quality-related challenges.
• Good communication and interpersonal skills to collaborate with cross-functional teams and support quality initiatives.

• Detail-oriented with a focus on maintaining product quality and compliance.
• Ability to handle multiple tasks and prioritize in a fast-paced manufacturing environment.