Ola Stephen

Experience

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  Bond chemicals industry

  May 2012 - Oct 2012

  QC Analyst

  1. Sample and analysis of incoming raw materials for chemical compliances.2. Analysis of intermediate and finished product for their chemical compliance.3. Continuous monitoring of conditions and performance of all instruments that are involved the analysis of drugs to know their accuracy and repeatability. This is done periodically depends on the instrument against a known standard and records.4. Writing and reviewing SOP for analytical specification and testing method for finished products.5. Maintenance of water treatment plant.6. Sample and analyze water. Show less

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  Central Science Laboratory

  May 2013 - Oct 2013

  Laboratory Analyst

  1. Preparation of sample for analysis.2. Operation of Atomic Absorption Spectrophotometer 3. Operation of UV spectrophotometer.4. Operation of High Performance Liquid Chromatography.

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  Bentos Pharmaceutical Products Limited

  Dec 2015 - Apr 2023

  1. Spear heading the implementation, monitoring and reporting Quality Assurance System across the value chain to ensure safety, quality and efficacy of products. 2. Collaborate with management and department heads to resolve problems affecting product quality; collaboration includes reacting, investigating and follow up with operations for non- conformance issues and working jointly towards resolution. 3. Carry out batch release of finished products. 4. Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure time closure. 5. Responsible for preparation, review and verification of QMS systems like deviation, change control and CAPA.6. Facilitate CAPA commitments and effectiveness checks, including initiation, tracking, trending, and closure track and management of deviations/ investigation/ CAPA systems in track wise. 7. Preparation and review of APQR.8.Leading quality activities, ensuring quality standards through process audits & product quality through product audits9. Identifying compliance risk to management & processes with remediation proposal and lead solution implementation. 10. Conducting trainings.11. Conducting quality inspection and product release programs for incoming and in-process materials, processes and finished goods12. Developing monthly, quarterly and annual Quality Review Report; updating field data and presenting same to senior management.13. Evaluating the performance of vendors based on various criterions such as percentage for rejections, quality improvement rate& so on14. Management of requirement for QA/QC including Budget, Instrument and Capital Equipment, Reference Standards, Pharmacopoeias etc.15. Serve as contact person for the organization to private and government bodies/regulatory body. Show less 1. Monitor and conduct GMP compliance inspections and audits of manufacturing and packaging areas and provide support to quality investigations. 2. Perform in-process inspection and released filling and packaging operation.3. Carry out qualification of equipment and validation protocols including cleaning, process and analytical. 4. Ensure compliance with SOPs, policies and procedures as required by company and regulatory agencies.5. Lead and participate in site quality and process improvement initiates and project teams. 6. Responsible for line clearance, start up and in-process checks of all area of manufacturing and packaging. 7. Performs area assessments and ensures compliance in all activities with cGMPs.8. Actively involved with investigation review board.9. On call coverage and collaboration with team of operations in the development for a resolution of quality issues.10. Implement CAPA.11. Assure the quality of product and batch records from filling and packing department.12. Evaluate Quality issues with QAM and other department.13. Revise SOPs & generate document change order. 14. Harmonize concerned departments to update the product range with the developed product, e.g. Sales to promote the product, Design and Engineering for drawings and specifications, Materials Department for sourcing suppliers and procurement, etc.15. Carry out risk management for all manufacturing process using tools like FMEA, FEM(C)A, fish bone diagrams, 5 Whys, HACCP etc. 16. Work with regulatory department to work on CTD Dossier for applications and renewal of FPP. Show less 1. Conduct laboratory investigations.2. Drive analytical laboratory compliance with cGMP / GLP and ICH guidance. 3. Ensure laboratory equipment are qualified, calibrated and process are validated using ICH guidelines 4. Supervise and coordinate laboratory activities to ensure compliance with supply chain, stability program, business needs and regulatory requirements. 5. Provide training to new development and QC analysts on various analytical techniques / new method developed in accordance with established regulatory, compliance and safety requirement.6. Oversee the maintenance of laboratory equipment; maintain stock level of analytical reagents and also procurement of reagents. 7. Analyze organic and inorganic compounds to determine chemical and physical properties.8. Prepare test solutions, compounds and reagents for laboratory personnel to conduct test analysis on raw material, intermediate products and finished products according to company’s procedure and policies.9. Interpret data and report scientific results.10. Provide technical and analytical support according to QC standard operating procedure.Utilize scientific equipments like (HPLC, UV-Spec, Dissolution apparatus, disintegration apparatus, melting point device, auto titrator, pH meter, autoclave etc.)11. Analyze samples from various sources to provide information on compounds present quantities of compound present using analytical techniques and instruments. Write technical papers and reports and prepare standards and specifications for processes, products and tests. 12. Monitor and schedule activities for calibration and maintenance of all lab instruments.13. Maintain batch records performance.14. Review evaluation and provide technical support of analytical skills as required to laboratory personnel. 15. General annual product report and discrepancy notice.Train new hires16. Participate and coordinate internal audits which include preparing for regulatory inspections. Show less

  • Quality Assurance Manager

    Nov 2017 - Apr 2023

  • Quality Assurance Executive

    Oct 2016 - Oct 2017

  • Quality Control Lead

    Dec 2015 - Oct 2016
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  Swiss Pharma Limited

  Apr 2023 - Mar 2024

  1. Provides QA review of the GMP data in support of release of commercial product as required.2. Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.3. Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.Supports quality oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.4 . Supports change control assessment, implementation, and closure as needed.5. Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.6. Identifies and facilitates continuous improvement efforts.7. Supports generations and maintenance of Quality Metrics to support process improvement activities as necessary.8. Identify and communicate risks and assist with risk mitigation plans as necessary Show less 1. To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),2. To assess the validation state of equipment’s through writing periodic review report and/or risk assessments3. To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),4. To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),5. To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,6. To support the production & technical services teams in the implementation of the validation activities,7. To ensure the periodic oversight of technical services activities,8. To review the modification proposed by the technical teams9. To ensure adequate level of quality on the floor through gembas and quality coaching of technical teams. Show less

  • GMP Specialist

    Jan 2024 - Mar 2024

  • Validation Specialist

    Apr 2023 - Mar 2024
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  Orange Group

  Mar 2024 - now

  Quality Manager