MOJI OLAFISOYE

• Responsible for the approval for release of all Customer Accugenix sample reports
• Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients
• Full knowledge of LIMS system, SAP and smartsolve
• Responsible for all quality operations of Accugenix laboratory
• Lead and direct all quality continuous improvement activities in Accugenix laboratory
• Aid in performing trainings for functional departments
• Collaborate in writing and editing technical documents including Standard Operating Procedures (SOPs), Quality Agreement, Technical Reports etc
• Oversee the lifecycle of quality system documents for the site including Deviations, OOS, Change Control, CAPAs and Customer Complaints
• Experience in internal and external audit such as client audit and relevant regulatory agency to the requirement of ISO xxxx, GMP and CFR 21 part 11.

• Maintenance of quality documentation from issuing, reviewing to archiving of GMP documentation
• Review and approval of quality documentation
• Full knowledge of Livelink and Trackwise system
• Assisting with the management of quality records and ensure all are closed on time.

• Perform maintenance and calibration of laboratory instruments, HPLC/UPLC troubleshooting.
• Experience running a chromatography system.
• Perform HPLC/UPLC/Assay/Uniformity of Dosage Unit/Dissolution of finished products, Stability batches, and testing of In-process samples.
• Perform physical testing of finished product, analysis of water content of finished products, average fill weight, UV/Vis analysis, IR, tablet and caplet hardness testing, disintegration, viscosity, and polarimetry testing.
• Review of chromatographic data, updating SOP, and Out of Specification.
• Full knowledge of ISO 17025.

• Perform HPLC assay, Content Uniformity, and physical testing on finished product, and, where applicable, stability testing according to relevant SOPs. Adhere to the site production schedule and accurately complete all documentation that supports testing procedures.
• Perform maintenance and calibration of laboratory instruments.
• Conversant with the hazardous properties of chemicals, and observe the safety rules.

• Performs routine/non-routine analysis of controlled drugs and Oral Contraceptives samples as per laboratory test methods and USP monograph.
• Fully trained and competent in Karl Fisher, Infrared Spectroscopy, HPLC, dissolution-UV-Vis, disintegration, friability, and hardness; tablet thickness and diameter analysis.
• Very experienced in the use of Labware LIMS, PDOC's, Empower, PowerPoint, Word, and Excel.
• Receives all controlled drugs and oral contraceptive samples into the laboratory and maintains the applicable logbooks and trackers.
• Calibration of lab instruments troubleshoots instruments when issues arise and follows up with the calibration department to ensure the issues are resolved.
• Completes all weekly housekeeping tasks and ensures the laboratory is audit ready always.
• Promotes safety in the laboratory and ensures all incidents are reported on the site safety reporting system.
• Moderator of the weekly laboratory meeting.

Reported and wrote up any laboratory deviations and non-conformances.

Perform risk assessment on laboratory reagents, be conversant with the hazardous properties of chemicals, and observe the safety rules.

• Preparation of Laboratory reagents and validation of expiry dates assigned to Laboratory reagents
• Physical testing and chemical analysis on raw materials, intermediate and finished products as per relevant test method specification
• Maintaining and following all relevant Standard Operating Procedures
• Testing of API, Stability and water sampling as per relevant test method specification using Titration Assay, wet chemistry techniques and Karl Fisher
• Use of HPLC
• Manual documentation and use of Laboratory Information Management System (LIMS)
• Calibration of Laboratory equipment
• Reporting any deviation and non-conformances to the Laboratory Supervisor
• Maintaining good housekeeping and hygiene within the Laboratory.