Vacancy title:
Team Leader – Documentation

[Type: FULL_TIME, Industry: Health Science, Category: Admin & Office]

Jobs at:
Quality Chemical Industries Limited

Deadline of this Job:
Tuesday, July 15 2025

Duty Station:
kampala | Kampala | Uganda

Summary
Date Posted: Thursday, July 10 2025, Base Salary: Not Disclosed

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JOB DETAILS:

Key Objectives and Responsibilities

1. Leadership: Provide leadership and direction for the development, implementation, and maintenance of the GMP documentation, ensuring alignment with regulatory requirements, industry standards, and company policies.
2. Documentation Team Management: Oversee the Documentation team responsible for the creation, revision, review, and control of all quality-related documents, including Standard Operating Procedures (SOPs), batch records, protocols, reports, logbooks, formats, etc., ensuring compliance with regulatory requirements and internal standards.
3. Document Control Systems: Oversee the use of the electronic document management systems (eDMS) or paper-based systems, including document creation, review, approval, distribution, retrieval, archiving, and disposal, in compliance with regulatory requirements and approved procedures.
4. Document Lifecycle Management: Manage the entire lifecycle of quality documents, from initial drafting through revision, review, approval, distribution, and obsolescence, ensuring timely updates and alignment with regulatory requirements and established procedures.
5. Quality Management System Development: Lead the development, implementation, and continuous improvement of the QMS framework, policies, procedures, and processes, incorporating best practices, risk-based approaches, and industry standards to enhance quality and compliance across all QA activities.
6. SOP Development and Review: Coordinate the development, review, and revision of SOPs and other quality documents in collaboration with subject matter experts (SMEs) and documentation teams for all departments, ensuring clarity, consistency, and compliance with regulatory requirements and best practices.
7. Training: Maintain training records and documentation for GxP training programs, oversee the training programs for the entire company for GxP activities, ensuring that employees are trained on relevant SOPs, policies, procedures, and regulations, and that training documentation is accurate and up to date.
8. Change Management: Manage documentation related to change requests, impact assessments, change implementation, log, etc. ensuring accurate documentation of all changes and their associated activities. Ensuring timely closure of change requests.
9. Computerized System Validation (CSV): Provide oversight and support for computerized system validation activities along with SMEs, including the preparation, execution, and documentation of validation protocols and reports for computerized systems used in manufacturing, packing, stores, QC, and QA operations.
10. Quality Metrics and Reporting: Monitor and analyze key performance indicators (KPIs) for documentation processes, preparing regular reports and presentations on document control metrics, trends, and areas for improvement.
11. Document Archival and Retrieval: Establish procedures for the archival (location charts), easy retrieval, and destruction of documents as applicable, ensuring that archived documents are stored securely and can be accessed promptly when needed for audits, inspections, or other purposes.
12. Risk Management: Oversee the risk management program for the facility; ensuring proper documentation processes and systems to identify potential risks and develop risk mitigation strategies to ensure compliance.
13. Qualification Documentation: Oversee the preparation of qualification documentation for equipment, equipment systems, and processes; ensuring that qualification protocols, reports, and related documentation are comprehensive, accurate, and compliant with the approved procedures.
14. Issuance of Formats and Logbooks: Oversee the issuance and control of formats and logbooks used in all operations, ensuring that they are current, standardized, and compliant with the approved procedures.
15. Continuous Improvement: Lead continuous improvement initiatives within the documentation section, identifying opportunities to streamline processes, enhance efficiency, and improve document control practices through the implementation of new technologies, tools, and best practices.
16. Cross-functional Collaboration: Collaborate closely with cross-functional teams, including Quality Control (QC), Regulatory Affairs, Manufacturing, Stores, Engineering, other QA sections, etc., to ensure alignment and integration of documentation processes with overall quality objectives.
17. Audit Readiness: Ensure readiness for internal and external audits of documentation processes by organizing documentation repositories, facilitating document retrieval, and serving as a point of contact for auditors during audits and inspections.
18. Qualifications and Experience Required

• Bachelor of Science in Industrial Chemistry, Chemical Engineering, Science Technology, Pharmaceutical Science, or Bachelor of Pharmacy
• Minimum of five (5) years working experience in a pharmaceutical manufacturing environment, including at least two (2) years in a supervisory or team leadership role.

Knowledge and Skills

• Proficiency in writing, reviewing and controlling Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other GMP-compliant documents.
• Familiarity with document management systems (DMS) and electronic documentation tools
• Good analytical and data review skills with attention to accuracy and compliance
• Excellent leadership and supervisory skills
• In-depth understanding of GMP and good documentation practices
• Excellent organizational and time-management skills
• Ability to work under pressure and meet deadlines
• Strong communication and interpersonal skills for coordinating across departments
• Ability to work collaboratively with others
• Understanding and adhering to relevant standards and regulations
• Detail Oriented and with excellent analytical
• Computer knowledge (proficiency in MS office)

Work Hours: 8

Experience in Months: 60

Level of Education: bachelor degree

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