Cosmos Pharmaceuticals is hiring a QA Assistant – Process Validation to support and execute validation activities across all manufacturing processes. This quality assurance role requires a diploma in pharmacy and at least 3 years of experience in a quality-related role within pharmaceutical manufacturing.
About This QA Assistant – Process Validation Role
The QA Assistant – Process Validation will be responsible for supporting and executing validation activities across all manufacturing processes to ensure compliance with regulatory and quality standards at Cosmos Pharmaceuticals.
This isn’t a general QA role. You’ll focus specifically on process validation activities including preparing validation protocols, collecting and documenting samples at various manufacturing stages, conducting physical analysis of samples, compiling validation reports, and developing hold time study protocols.
You’ll work closely with the quality control team, production department, and quality management to ensure strict adherence to cGMP (current Good Manufacturing Practice), GDocP (Good Documentation Practice), and ALCOA principles for data integrity and documentation.
The position requires someone who understands pharmaceutical manufacturing processes, regulatory requirements, and quality documentation systems. You’ll support quarterly updates of the Validation Master Plan and report any non-compliance arising during validation protocol execution.
Key Responsibilities
Your day-to-day duties as QA Assistant – Process Validation will include:
Validation Protocol Development
- Prepare process validation protocols outlining execution plans for validation activities
- Develop clear, detailed protocols that meet regulatory and internal quality standards
- Ensure validation protocols align with current cGMP and regulatory requirements
Sample Collection and Analysis
- Collect and document samples at various manufacturing stages during validation processes
- Submit samples to QC (Quality Control) for analysis in accordance with validation protocols
- Conduct physical analysis of samples obtained during validation processes
- Ensure proper sample identification, handling, and documentation throughout the process
Validation Execution and Reporting
- Execute validation activities according to approved protocols
- Compile and prepare comprehensive validation reports upon completion of validation activities
- Document all validation findings with accuracy and completeness
- Ensure validation reports meet regulatory and internal documentation standards
Hold Time Studies
- Develop and execute hold time study protocols for manufacturing processes
- Generate corresponding reports documenting hold time study findings
- Ensure hold time studies comply with stability and quality requirements
Compliance and Documentation
- Ensure strict adherence to cGMP (current Good Manufacturing Practice) standards
- Maintain compliance with GDocP (Good Documentation Practice) requirements
- Apply ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for data integrity and documentation
- Report any non-compliance arising during validation protocol execution
- Escalate deviations or quality issues to appropriate quality management personnel
Validation Master Plan Support
- Support quarterly updates of the Validation Master Plan
- Contribute to the ongoing improvement of validation processes and documentation
- Maintain up-to-date knowledge of validation requirements and best practices
Required Qualifications
Education
- Minimum Diploma in Pharmacy or a related field (Pharmaceutical Technology, Industrial Chemistry, or similar pharmaceutical sciences discipline)
Experience
- At least 3 years of experience in a quality-related role, preferably within pharmaceutical manufacturing
- Hands-on experience with validation activities, protocol development, or quality control processes
- Familiarity with pharmaceutical manufacturing environments and GMP requirements
Technical Knowledge
- Strong analytical and problem-solving skills
- Good understanding of GMP (Good Manufacturing Practice) and regulatory requirements
- Knowledge of analytical techniques used in pharmaceutical quality control
- Strong knowledge of quality documentation systems and data integrity standards
- Understanding of ALCOA principles for documentation and data integrity
- Familiarity with validation concepts including process validation, cleaning validation, and hold time studies
Computer Skills
- Proficiency in MS Office applications (Word, Excel, PowerPoint, Access)
- Ability to create detailed documentation, reports, and presentations
- Experience with electronic documentation systems is an advantage
Professional Competencies
- Effective communication skills (written and verbal)
- Strong numerical and presentation skills
- Excellent attention to detail and accuracy
- Ability to work methodically and follow detailed procedures
- Strong organizational and time management abilities
- Ability to work independently and as part of a cross-functional team
What Cosmos Pharmaceuticals Offers
Employment Type: Full-time, permanent position (COB – Close of Business appointment)
Location: Kenya (specific manufacturing site to be confirmed with shortlisted candidates)
Industry: Pharmaceutical Manufacturing
Work Environment: You’ll work in a regulated pharmaceutical manufacturing environment with modern quality assurance systems, supporting validation activities across production processes. Cosmos Pharmaceuticals operates in accordance with international GMP standards and regulatory requirements.
Professional Development: Opportunity to develop expertise in pharmaceutical process validation, work with regulatory compliance frameworks, and advance your career in pharmaceutical quality assurance within an established manufacturing company.
For more pharmaceutical and manufacturing opportunities in Kenya, browse Kenya jobs on ActiveJobs.
How to Apply
Application Deadline
10th May 2026, COB (Close of Business)
Documents Required
Submit your application to Cosmos Pharmaceuticals with the following documents:
- Updated CV/Resume – Include your diploma in pharmacy, 3+ years of quality-related experience, and specific validation or QA activities you’ve performed
- Cover Letter – Explain your interest in this QA Assistant Process Validation Kenya position and highlight your understanding of cGMP, validation processes, and pharmaceutical manufacturing
- Diploma Certificate – Copy of your Pharmacy diploma or related pharmaceutical sciences qualification
- Professional Certificates (if applicable) – Any additional quality assurance or pharmaceutical manufacturing training certificates
How to Submit Your Application
Email your complete application package to:
recruitment@cosmos-pharm.com
Email Subject Line: Application: QA Assistant – Process Validation
Applications received after 10th May 2026 (COB) will not be considered. Only shortlisted candidates will be contacted for interviews.
Note: Cosmos Pharmaceuticals is an equal opportunity employer committed to maintaining the highest standards of pharmaceutical quality and regulatory compliance.
