Geoffrey ogoye

- Clean area qualification

- Supply Chain related deviations investigations.

- Quality Deviation investigations

- CAPA creation and implementation

- Change Control and Management

- Training of the Quality Management teams

- Quality Audits and Inspections

- HVAC systems qualification

- Evaluation of Product/Process Deviation Report (OOE/OOS) and/or Reportability.

- Creation of the Regulatory Compliance Files (RCF from the Module 3 of e-CTD for the Sections 3.2.S and 3.2.P) approved Dossiers for Contract Manufacturing Organizations and for regulatory alignment with the e-CTD system.

- Preparation of the legal documentation for product registration with ANVISA and INVIMA, EMA, Health Canada, COFEPRIS and ANAMED.

- Product life cycle management including PACM.

Data handling in risk management and evaluation in the CMC

- Product/Process Deviation (OOE/OOS) Investigations.

- Validation and Revision of Validated Analytical Methods.

- Technology transfers for discontinued products to new MAHs.

- Sampling raw materials (APIs and Excipients and intermediates) for conformity with the production lots/batches specifications.

- Change implementation and evaluation through PCDA

- KPI Evaluation for ongoing processes.

- Revision of Certificate of Analysis for Inputs and excipients.

- Quality Risk Management oversight.

- Development of Drug Formulation, testing and achieving compatibility between the excipient drug components NDA (phytopharmaceuticals).

- Development adequate Drug packaging systems for a variety of phytopharmaceuticals.

- Development of Analytical methods for finished NDA.

- Process, Installation, Equipment and Operational qualifications in collaboration with a multi-disciplinary team.

- Pre-registration Stability studies on raw materials, manufacturing intermediates and finished products.

- Validation and/or Verification of Analytical methods, both In-House and Compendial using HPLC and GC

- Validation a of analytical methods

- Periodic Product Review Performed

- CMC Release Testing

- Supplier Qualification

- Process Verification and KPI follow up

- Execution, Revision and updating of the GMP/GLP CMC protocols.

- Control of filling and packaging of sterile and parentheral products

- Deviations Investigation OOS/OOT/OOE

- Implementation of the approved GMP/GLP protocols for the CMC.

- Batch reconciliation before release.

- Continuous improvement follow-up.

- Statistical Process Control.

- Process improvement strategy

- Batch reconciliation before release.

- Continuous improvement follow-up/KPI evaluation.

- Creations of LIMS for internal resource corporate management.

- Revision of Certificate of Analysis for Inputs and excipients.

- Customer Complaint investigation.

- Collection, preparation and analysis of samples from clients for Work Place Drug testing, suspicious death investigations and child custody disputes.

- Regular maintenance of the Chromatography System, cleaning of the columns, ion source, replacement of the filament, tuning, leak-check and calibration gas monitoring for the GC-MS system.

- Drafting of Drug Test Reports for companies and or law courts in cases of workplace and child-custody dispute drug testing.

- Sampling of raw materials (API, Excipients and Intermediates) on arrival at the plant.

- Stability studies on raw materials, manufacturing intermediates and finished products.

- Implementation of the approved GMP/GLP protocols for the CMC.

- Drafting of Validation Reports and final copies of batch release testing.

- Execution, Revision and updating of the GMP/GLP CMC protocols.

- Validation of analytical Methods.