Process/Equipment Validation Lead at Adexen

Responsibilities

• Execute Validation activities (from planning stage to execution)
• Maintain systems in a validated state
• Partake in relevant project meetings/coordination of validation meetings
• Generate validation protocols (DQ/FAT/IQ/OQ/PQ/PV)
• Execute validation protocols (IQ/OQ/PQ/PV)
• Write validation reports (DQ/FAT/IQ/OQ/PQ/PV)
• Write Validation Summary report
• Ensure deviations from pre-approved protocol are managed accordingly
• Equipment decommissioning
• Conduct validation reviews/equipment requalification in line with periodic validation review
• Contact person to interface with process owners/other departments on site to ensure systems are in line with the Validation Life Cycle Approach
• Support in the development of User Requirement
• Lead and execute the Commissioning and Qualification (C&Q) of validation projects to ensure the C&Q is in line with the pre-approved URS and relevant Company/regulatory policies.
• Execute temperature mapping for controlled chambers such as cold rooms, freezers, warehouse, etc.
• Work with the project group/teams during the C&Q to ensure compliance with Company policies and appropriate regulatory bodies (NAFDAC)
• Work with the New Product Development Manager to coordinate with other cross functional resources (manufacturing operations, engineering, etc.) in identifying prerequisite documents needed pre- and post-qualification
• Work with the Product Development Manager in the preparation of Validation Documents for Audit readiness
• Review change controls documents relating to technical and process changes during the execution of the validation activities.

Desired Skills and Experience

• B.Sc./HND in Industrial Chemistry, Biochemistry, Biological and Physical Sciences and other related disciplines/Computer literacy is an added advantage.
• Minimum of 3 years practical experience in Pharmaceuticals/Food and Beverages with knowledge of GMP and Validation.
• Listening Skill; Project Management; Quality Management Standards; Validation and Report Writing
• Knowledgeable in Good Manufacturing Practice (GMP). The holder should be familiar with the operations of a Drinks industry.
• Ability to prioritize and act appropriately is essential.
• Ability to provide comprehensive situation reports and hold secret of all confidential information relating to the company’s business.
• Display of innovation and improvement in systems are necessary for career development.
• Able to carry out work with agreed/approved specifications and limits in line with Quality Standards requirements