Quality Assurance Technician at Lafayette Resources

Our Client an accredited company involved in the management of temperature-controlled warehouses and specialized in supply chain management seeks to fill the position of a Quality Assurance Technician in Kenya and we are thus hunting for exceptional talent for the role

Role purpose

The individual will assemble customer orders from storage or inbound shipments to a standing area for outbound loading. This is a highly active role which requires the individual to work safely, accurately, and efficiently to meet customer needs.

Roles

• Successfully perform all primary activities which include providing daily quality assurance to operations, review of electronic batch records and associated documents within the manufacturing facility, provide support on change control processes, and participate and support internal and external audits.
• Assure compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and write and implement the company’s Quality practices.
• Review electronic batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Provide assessments to support day to day change control processes (insignificant changes and return to operations) in accordance with internal procedures and ensure compliance with the FDA and ISO requirements.
• Good understanding and knowledge of current regulatory requirements and serve as a plant resource for compliance to these requirements

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or other technical field and 3-5 years of relevant experience in Quality with a pharmaceutical/Food company or other similarly regulated industry.
• General knowledge of biotech manufacturing theories and processes preferred.
• Knowledge of Pharmacy and Poison Control Board certification and NEMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP) preferred.
• Key skills
• Should have strong communication and interpersonal skills with great attention to detail
• Should be a Self-motivated individual and good team player
• Must possess excellent sales skills, outgoing, client facing temperament
• Must have a strong business acumen with the ability to make a significant contribution to performance and profitability;
• Should poses strong strategic thinking and execution skills;