Emmanuel Anane Email and Phone Number

• Cephalosporin, Sterile Injectables, and OSD.• Protocols, SOP, STP, URS, AMV, Calibration, QMS, HPLC, CTD, Packaging material testing, execute and prepare Stability study records for drugs registration and for drug quality shelf life.• Specifications, Stability Study, IQ, OQ and PQ for laboratory equipment’s,.• Request for required logistics necessary for general laboratory functioning.• Prepare and execute method validation and method verification.• Perform quality standard training for new and existing staff.• Devised specifications for processes and products.• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.• Adhered to all legal, safety and health standards.• Managed and achieved quality documentation and participated in internal and external quality audit.• Maximized quality and reduced costs by maintaining QC objectives.• Providing feedback and interpretation of results to production and management.• Collaborate with contract representatives and oversaw quality control implementations and reporting.• Evaluate quality problems and performed action to identify and resolve issues.• Calibrates lab instruments and scales.• Increased customer satisfaction through adherence to all quality standards and customer requirements.

SKILLS:• Setting up of a Quality Control Laboratory.• Develops analytical Methods for new products.• Prepare Protocols • Standard Test Procedure. (STP)• Standard Operating Procedure. (SOP)• Calibration and verification of Laboratory Equipment’s.• Analytical Method Validation• Prepare report for analytical method validation • Expect in preparing. products specifications• Expect in preparing dossier for drug registration.• GLP, GMP, QMS, and Method validation expect.• Prepare URS for quality Control Instruments.• Comparative dissolution• Perform IQ, OQ, PQ for Quality Control Instruments. • HPLC qualification and calibration.• Microsoft Excel• Microsoft Word• Microsoft PowerPoint• Annual Product Quality Review

• Beta Lactam, and OSD.• Plan, execute and prepare Stability study records for drugs registration and for drug quality shelf life.• Prepare protocols for products, process and equipment’s. • Prepare IQ, OQ and PQ for laboratory equipment’s.• Prepare • Calibration and verification of Laboratory Equipment’s. • Prepare and execute method validation and method verification.• Perform quality standard training for new and existing staff.• Devised specifications for processes and products.• Prepare logistics necessary for general laboratory functioning• Adhered to all legal, safety and health standards.• Managed and achieved quality documentation and participated in internal and external quality audit.• Maximized quality and reduced costs by maintaining QC objectives.• Providing feedback and interpretation of results to production and management.• Collaborate with contract representatives and oversaw quality control implementations and reporting.• Evaluate quality problems and performed action to identify and resolve issues.• Calibrates lab instruments and scales.• Increased customer satisfaction through adherence to all quality standards and customer requirements.

• Prepare stability protocols and reports for products• Prepare specifications for raw materials and finished products.• Analysis of packaging materials.• Devised specifications for processes.• Updated quality control standards, methods and procedures to meet compliance requirements.• Adhered to all legal, safety and health standards.• Managed and archived quality documentation and participated in internal and external quality audits.• Provided observations, took measurements and performed tests at various stages according to quality control plan.• Rejected defective products and approved correct products.• Collaborated with contract representatives and oversaw quality control implementations and reporting.• Increased customer satisfaction through adherence to all quality standards and customer requirements.• Developed and deployed production control plans, including creating all related work instructions and procedures.• Calibrated instruments and scales in production area and quality lab.• Evaluated quality problems and performed action to identify and resolve issues.• Liaised with Management to organize and perform quality standard training for new and existing staff.• Minimized costs and maximized returns resulting in savings.• Inspected inbound and outbound products for compliance with established industry standards, company policies and procedures.

• Review report of quality control chemist.• Supervised the chemist in the laboratory.• Developed in-house methods of analysis.• Conduct audit and prepare CAPA • Prepared product specifications.• Carry out maintenance work on HPLC.• Prepared stability data.

• Analysis of finished product and stability sample.• Carry out the following Test, Identification, Assay, content uniformity, Dissolution, Impurity, water content, using instruments like FT-IR, HPLC, Dissolution Tester, UV spectrophotometer, Karl Fischer titration, PH meter, etc.• Perform in–Process testing or physicochemical testing of drugs, such as tablets, Capsules, sachet, blend, syrup. Tests includes hardness leak test, uniformity of weight or weight variation, friability, Thickness, Diameter, weight per mL, Tap density,) etc.• Perform sampling and testing of packaging materials like bottles, cartons, caps, labels, Inserts, etc.• Conduct data review • Perform visual assessment of products to evaluate conformance with quality standards.• Perform line clearance for production to commence• Check manufacturing processes, ensuring they are properly followed.• Carried QA/QC quality audit.• Check product conformity, e.g., raw materials, granulation, compression and packaging.• Supervised online process.• Ensure cleaning of machines and the environment.• Enforce safety procedures at the work place.