About the role
Support the delivery of Project LENC documentation by ensuring all document-related activities are completed accurately, compliantly, and on time, while also supporting Process Assurance activities at the Consumer Healthcare (CH) Nairobi site to ensure all processes are initially qualified and maintained in a qualified state in line with company Quality, Compliance standards, and relevant regulatory requirements.
Key responsibilities
Batch Record Review & Tracking
Support the review of batch records impacted by LENC project changes.
Maintain tracking logs to monitor status, progress, and completion of batch record updates.
Identify gaps, inconsistencies, or missing information and escalate as required.
Documentation Coordination
Coordinate updates of controlled documents in line with project timelines and quality standards.
Initiate and manage document review workflows within the document management system.
Follow up with stakeholders to ensure timely review, approval, and closure of documents.
Compile review comments from cross-functional teams in a structured manner.
Track and manage action items arising from document reviews.
Ensure effective follow-up and closure of all actions.
Compliance & Quality Support
Ensure all documentation activities comply with GMP and internal quality standards.
Support audits and inspections by organizing and retrieving documentation when needed.
Maintain accurate records and documentation traceability.
Qualifications and skills
Required
BSc. Chemistry, Biochemistry, Chemical Engineering or Process Engineering, Industrial Chemistry.
Manufacturing experience/background preferable pharmaceuticals and/ or FMCH organizations.
Other Skills/Qualifications
Strong attention to detail and organizational skills.
Good understanding of documentation practices (GMP knowledge is an advantage).
Effective communication and stakeholder coordination skills.
Ability to track, prioritize, and manage multiple tasks.
Proficiency in Microsoft Office (Excel, Word, PowerPoint).
Proactive and accountable.
Strong follow-up and coordination mindset.
Ability to work in a structured and compliant environment.
Team-oriented with a continuous improvement mindset.
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