CHARLES ASHU

CSV QA Engineer at Jansen Vaccine Bern

➢Review and approval of Protocols

➢ Assist in Audits

➢Working to GAMP 5 standards

➢Review and approval of Validation plans, RTM, FMEA, CAPA

➢Attending daily meetings to plan QA tasks. Help in the review and approval of , SIA and RA

➢Ensure GMP Compliance is adhered to throughout an investigative process

➢Liaise with SME to determine severity of Non conformances and determine if a Capa or Deviation is required

➢Investigate CSV related deviations and assist in drafting deviations.

QA CSV engineer at Fuji Film Denmark

➢Review and approval of RA, FMEA, Validation Plans, RTM in kneat.

➢Review and approval of Executed protocol in kneat

➢Taking Part in meeting to decide leveraging of Protocols from commissioning and Qualification.

CSV Validation Engineer at Biogen Lauterbach Switzerland

➢Commissioning and Qualification MES (Syncade), Syncade Interface with Delta V, Syncade Modules, Syncade Components, Syncade Manufacturing Core Functions.

➢Working to GAMP 5, 21 CFR part 11 standards

➢Responsible for authoring deviations and CAPA in cases of out of specification results.

➢Laisse with SME to arrive at possible solutions to deviations and or CAPA and to

➢Ensure GMP Compliance is adhered to throughout an investigative process

➢Receiving of manufacturing recipes from Vendor (Emerson), review vendor documents and storing them in an electronic document, performing installation and functional Confirmation of Syncade.

➢Attending daily meetings quality meetings.

Participate in risk assessments and requirement traceability sessions.

➢Performing Gap analysis

➢Review and approve documentation for Symca online.

➢Drafting and designing and approving of PCRF

➢Drafting and execution of Installation and Functional

confirmation Protocols (ET Class, MCF, Interfaces and End to End testing)

➢Carrying out CSV impact assessments on PCRF

Writing and executing Installation confirmation and functional confirmation protocols for systems

Commissioning of Syncade modules

Commissioning and qualification Validation engineer for Clean Utilities at MSD Biologics in Burgwedel Germany.

➢Cycle Development for Autoclaves and Depryogenation Tunnels Authoring URS, IQ and PQ for legacy, modified and New Autoclaves.

➢Testing Steam quality as per EN285

➢Working with the depryogenation tunnel and fill finish line. Tunnel was used for sterilisation of vials at a temperature of 270˚C and sent to the cooling zone for onward transfer to the filling machine. After filling and capping the product is transferred using cross flow trolleys to the sealing line.

➢Working on the commissioning of Decontamination of A12 Getinge Autoclave used of Decon (IQ, OQ, PQ and Cycle Development)

➢Cycle Development, Commissioning, Qualification and of Getinge A9 Autoclave (Cycle

➢Development for sterilisation cycles, IQ, OQ and PQ)

Successfully handing over equipment to manufacturing department after successful completion of Validation activities.

C&Q at Abbotts Pharmaceutical in Weesp Nord Holland.

➢Main Role included Strategic Planning and designing the C&Q approach for projects, developing master plans, and defining the scope for both GxP and non-GxP systems and the design of pre-Commissioning, commissioning IQ and OQ of Process equipment and Utilities.

➢Documentation Management: Authoring and approving crucial documents, including User Requirement Specifications (URS), Functional Specifications (FS), Design Qualifications (DQ), and FAT/SAT (Factory/Site Acceptance Testing) documents.

➢Performing execution oversight through leading the team in executing, reviewing and approving IQ, OQ and PQ protocols.

➢Take part in audit readiness and make sure that the team adheres to compliance.

➢Manage Deviations and change controls.

➢ Report any possible delayance to site leadership in case of downtime.

➢Successfully handing over equipment to manufacturing department after successful completion of Validation activities

➢Manage C&Q Engineers through task distribution and excellent communication amongst team members in the event of a shortage in staff.

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➢Commissioning and qualification, requalification and Validation of Controlled storage systems (CSE), Using the Kaye Validator and tiny tags.

➢Review and execution of protocols. Reviewing analysis and periodic reviews, writing Validation reports and assist and or lead in the closure of executed protocols.

➢Carrying out thermometric Mapping of cold systems and warehouse, downloading the data from data loggers and writing reports

Main Role included Strategic Planning and designing the C&Q approach for projects, developing master plans, and defining the scope for both GxP and non-GxP systems

Design commissioning protocols for Gxp and Non GXP systems

➢ Working in an aseptic environment carrying out remediation work on aseptic lines, full vessel temperature mapping, carrying out SIP, attend change control meetings, interpret P& ID diagrams using worse case locations to determine steam boundaries and carrying out steam sterilisation.

➢ Supervise and Carry out SIP, thermos mapping using the Kaye Validator and Yokogawa to monitor temperatures of manufacturing process Vessels, modified transfer lines, rigid isolator and cold rooms.

➢ Take part in drafting Change controls and attend change control meetings and involved in bringing inputs from the Validation point of View. Lead morning team meetings to be able to distribute and plan daily tasks

➢ Authoring and execution of IQ and OQ and write summary reports after analysing results.

➢ Making sure timelines are met and Protocols executed within the set time and equipment handed back to production.

➢ Development of strategies within the team on how to prevent deviations. Investigating deviations and putting in place corrective action (CAPA).

➢ Commissioning and qualification of mobile and static vessels and autoclaves and incubators.

➢ Achieve remediation and all aspects of equipment successfully handed to production

➢ Commissioned and qualified a new Homogeniser. Writing and Execution DQ, IQ, OQ, PQ

➢ Commissioning, qualifying and Validating new 2000L vessels.

➢ Carrying out retrospective Validation for legacy equipment

➢ Writing equipment and process risk assessments

➢ Attend change control meetings

➢ Investigating Deviations and helping in the Closure of CAPA

➢ Review of Protocols on behalf of Validation department for final submission to QA.

➢ Support the writing of Annual Quality product reports.

➢ Carry out thermometric mapping using the Kaye and Data loggers.

➢ Successfully creating a Validation file for each equipment after successfully completing retrospective

Validation

➢ Working to ISO9001 and ISO13485 standards and Carry out both process and equipment validation. Use track wise to initiate Change control and generate protocols.

➢ Commissioning and Qualification

➢ Validation of filling and packaging lines, cartoners, Labellers, bottle blowers, pharma code readers, shrink wrappers and fillers.

➢ Use of Kaye Validator to carryout thermo mapping. Generate Change controls on track wise

➢ Carry on Validation of both equipment and process in line with company’s Validation Mater plan.

➢ Execute protocols, organise briefings with production department, design datasheets, Revise the

Validation parameter summary, update SOP’s and Batch manufacturing records at the end of

Validation Campaign and take part in investigations. I also work to ensure right first time and contribute to projects in support functions.

➢ Resolve problem report. Investigate deviations through CAPA. Initiate IQ, OQ and PQ and also take part in PPVR (Periodic Validation review). Use of Qumas to revise VPS (Validation Parameter summary). Also partake in the revision of site Validation master plan.

➢ Training new hires and take part in meetings to represent Validation department.

➢ Carryout activities aimed at audit readiness.

➢ Authoring Validation protocols for equipment and Compiling Traceability Matrix for equipment ➢ Carry out high impact risk assessments for in Use.

➢ Working to achieve the manufacture of budesonide (An inhalant for asthma)

➢ Operation and maintenance of the Homogeniser and monitoring the process through the use of SCADA in the manufacture of Budesonide in Clean room environment by mixing the excipient and Active with the homogeniser to realise a homogenous solution.

➢ Collection of samples and conduction of conductivity and Ph test Updating SOP and help in the training of new hires.

➢ Taking part in drawing up risk Assessments and attending daily safety meetings. Carrying on minor engineering work on the homogeniser as well as opening and coupling manual valves and changing diaphragms.

➢ Assist in process Validation work. Collecting and evaluating data, from the process design stage throughout production to make sure the process works according to design parameters.

➢ I am well trained in the completion of chemical batch manufacturing records, working from the control room and on plant using SCADA to adjust and monitor processes in the manufacture of API, filling step real time upon performing each and every task. Proper Understanding of COSHH, DSEAR, UN for Waste disposal and transportation of Hazardous goods.

➢ This role amongst other includes the use of Hydrogenation and a lot of other chemicals in the manufacture of API. Abatement through the use of carbon drums in protecting the environment is something am well versed in. Am also trained in the use of Tornado and the use of Vacuum in production process. My role also involved actively taking part in validation work of both the process and equipment.

➢ Doing IPC samples, KF and RSA and RA, Working on the effluent, carrying out swabbing for WFI (water for injection), water optimization, sludge treatment and reverse osmosis using centrifuge. Also undertake some chlorinification and purification of water plant.

➢ Also used tornado hoods and oxygen mask in carrying out certain tasks. I am also well versed in the use of diaphragm pumps to transfer chemicals from the secluded chambers to vessels upstairs for mixture with excipients.

➢ Warehouse stock checking, accepting incoming goods and dispatch of manufactured goods. Stacking and offloading of racks using electric and diesel forklifts.

➢ As most senior process technician in my team I always deputised for the supervisor in times of absence or holidays. Planning workload, mentoring staff and making sure production timelines were adhered to. Ensure coaching and training of new hires to make sure they become proficient in their jobs. Reviewing manufacturing batch records for onward transmission to Quality for final review.

➢ Use of MCS manufacturing control system through Delta V in the control room to monitor and adjust processes in the manufacture of embrel (A drug used to cure of arthritis). This was an up and down stream manufacture of embrel. Upstream consisted of cell culture and Media and downstream was made up of purification and buffer. Upstream manufacturing started at the inoculation lab were growing of the cells commenced. The cells are then fed with perfusion media in bioreactors where they are latter fermented and harvested.

➢ Gained experience of working to quality systems such as GMP and using SOP’s.

➢ Training of New hires.

➢ Writing Risk assessments and making sure safety is adhered to.

➢ Manufacture and test of buffers.

➢ Carrying out CIP’s and SIP’s.

➢ Making sure manufacturing timelines are met.

➢ Carrying our Quality check of production batch records to ensure quality compliance.

➢ Ensure manufacturing area is cleaned after production of each batch.

➢ Deputise for supervisor and report to manager and ensuring adherence to manufacturing and development plan.

➢ Carrying out freeze – thaw operations and assist in filtration of final product.

➢ Ensuring company’s values are always adhered to.

➢ Support validation and standardization of equipment.

➢ Ensure day to day stock control is taken using SAP, MCAS and ensure products for testing are logged to the laboratory using LIMS.

➢ Efficient in the use of Tornado hoods.

➢ Assist and partake in process Validation work. Collecting and evaluating data, from the process.

design stage throughout production.

Job Title: Clean Room/Facilities Supervisor.

➢ Supervising a shift of 10 cleaners in grade A, B C and D areas. Ensured the work load was evenly distributed amongst members of my team, managing their growth and training and ensuring enough cover through proper planning of holidays of staff in my team.

➢ Clean room marshal. Making sure clean room principles are adhered to prior and after entering the classified area.

➢ Liaising with shift supervisor and production manager to determined areas needing sanitization and conduct weekly and monthly sanitization of Clean rooms. Also worked as clean room marshal.