Founder and Owner of HealthyData.Science

* Implemented and performed the CSV for the Walk-in Incubators in the new micro-laboratory, which
utilized ICDAS 2.1 software (Intelligent Control and Data Acquisition System). This incorporated
drafting and executing several CSV test scripts which adhered to CFR 210, Part 11
* Enforced Data Integrity solutions across site wide activities, which incorporated ALCOA. This was
carried out on a day-to-day basis with the operators, vendors and general staff.
* Performed the planning and drafted/ managed the validation system life cycle documents for Class
II MBSC's, LAF's, Dynamic Pass Boxes and a glass manufacturing vessel. This included overseeing
the engineering studies and training the full-time employee and writing the reports. This
equipment was part of the remediation schedule, as they did not adhere to site regulations.
* Performed FMEA (risk assessment) on glass manufacturing vessel

* Performed periodic reviews & drafted reports for upstream/ downstream Biotech equipment/ systems
in the aseptic suite, to ensure they remained in a validated state and no cumulative impact
resulted during the review period
* This entailed an evaluation of the calibration and maintenance schedules (using Maximo) and all
associated change controls, deviations, CAPA's and validation documentation (using Trackwise),
during the specified review period.
* Carried out technical reviews/ consulting for performance verification autoclave reports. This
entailed reviewing sterilization data for empty/ loaded chamber temperature distribution tests.
Key criteria included reviewing Lethality, temperature during exposure phase, equilibration
times, saturated steam conditions and Biological indicator results.
* Provided input in finalizing deviations for aseptic equipment in the clinical manufacturing
plant, which entailed liaising with QA and the technical team
* Developed validation protocols and reports for steam in place/ sterile hold time and media hold
time study for harvest area vessels
* Provided technical and GMP review (against industry standards) of turnover package for clinical
manufacturing plant

This was a start-up in the oil and gas industry. Catastrophic failures offshore, are many more times
expensive than onshore failures. This is due to lack of quality, trending data, geographic location
and inaccessibility. MMS implemented solutions for forward planning and predictive maintenance
systems. My role was to build the web platform and online presence, introduce new products (data
acquisition and monitoring systems), technical articles onto the web platform, and deal with global
customer enquiries and familiarize myself with predictive maintenance concepts and associated data

* SAT review/ witnessing/ testing and execution in ETIMs (extensive time information management
system) for ICOS autoclave
* Execution of SAT, IQ, OQ and Cycle Development protocols for autoclave in sterile manufacturing
environment
* Update of URS/FDS/SDS/ drawings and TMX for autoclave
* Troubleshooting and reporting of software/mechanical and electrical issues on a daily basis.
* Drafting and execution of CSV test scripts for Autoclave
* Responsible for deviation management to handle all issues. This entailed escalating issues in
whiteboard meetings, defining root cause, investigation with the team and implementing a
corrective action (with agreement from QA)
* Flew to client site in Italy with team, to participate in handling of software/ documentation
issues
* Preparation/drafting of Cycle Development Protocol for Sterilization and Drying of 4 different
production loads and Filter Steam in Place recipe
* Participated in SPS (Systematic Problem Solving) to address sterilization issues with hoses. This
involved using a quality tool (Fishbone diagram) to determine root cause and establishing a CAPA
(to prevent re-occurence).
* Raised and implemented change control for software modifications to clean steam valve for
Autoclave
* Preparation of PQ Protocol which included revised TC and BI distribution rationales/
identification of hardest to heat items to establish worst case conditions

* Duties were to organise and lead validation working parties for smaller projects, providing a
validation coordination service to Validation Manager
* Drafted Validation Summary Report for Multi Dose Powder Inhaler in Respiratory. Included
investigating missing swab results, organising a working party to discuss and remediate
actions. Report involved collating, graphing and discussing all cleaning campaign data over an
extended period of time.
* Review of Cleaning Validation Monitoring Annual Report for Respiratory. Participated in Review
of Out of Specs/ Deviations and participated in remediation work/ drafting meeting minutes.
* Participated in a Quality Investigation Report which involved establishing a CAPA during a
6-step process. This was initiated due to potential problems in swab locations. Timelines for
completion of CAPA were established, based on risk and criticality. Hence, a product quality
risk assessment was conducted to ensure no impacted batches.
* Drafted Validation Summary Report for OSD Dispensary. This involved collating cycle print outs
for the washing recipe, clean campaign charts and ensuring the cleaning SOP is updated to
include new instructions for washing dispensary parts/ revised cleaning parameters.
* Data review/ mining of Cleaning Validation Status for OSD Products, following an update of the
Residual Contamination Limits. This was Audit preparation work.
* Reported feedback in daily accountability meetings to escalate issues.

* Coordination of Cleaning Validation across 3 Production Suites which entailed manual and
automated cleaning processes and basic understanding of CIP/SIP Cycles

* Cleaning development studies carried out for Vessels and Filling Line, to determine acceptance
criteria, in order to adhere to new Merck Global Cleaning Validation Policy

* Wrote cleaning validation protocols, to adhere to new Merck Global Cleaning Validation Policy

* Execution and rinse/ swab sampling, pH measurement, visual inspection and liaising with QC
Analytical Laboratory and Production Staff

* Update of Cleaning Validation Master Plan and Cleaning SOPs, to adhere to new Merck Global
Cleaning Validation Policy
* Participated in fortnightly Global Teleconference for update of new Cleaning Validation Policy
across Merck Worldwide
* Implemented and presented new cleaning validation strategy to QA group.

* Participated in Technical bid analysis of proposed Testing & Balancing/ Clean room
certification contractors
* Management and expediting of sub-contractors and interfacing with clients
* Drafting and execution of CSV test scripts for Isolator
* Deviation investigation and resolution of mechanical and software issues
* Technical management of Sub Contractors for Class II MBSC and Inoculum Isolator systems.
Isolator included VHP unit which entailed separate IQ/OQ
* Update of UR for MBSC and Isolator
* Commissioning of Isolator and MBSC, including System Lockout and writing Safety Permits
* Supervising installation, SAT review/witnessing/testing and drafting/ execution of IV, IQ, FT
and OQ protocols for above systems
* Troubleshooting and reporting of software/mechanical and electrical issues on a daily basis.
* Receipt Verification/ Quality Review of Clean and Black Utilities and preparation of turnover
pack to client
* Wrote Commissioning and Qualification Summary Reports to enable handover/ TCCC approval for
client