Simon Joseph Cooper has over 20 years of experience in quality assurance and quality control roles in the pharmaceutical industry. He is seeking a senior role that provides management responsibilities and opportunities for further skills development. His experience includes batch documentation review and approval, internal auditing, oversight of quality systems, and ensuring compliance with GMP requirements. He has a BSc in Applied Biochemistry and Microbiology and is interested in roles involving Qualified Person training.

1. Simon JosephCooper
23 Barkfield Lane, Formby, Merseyside,L37 1LY
Telephone: 01704 875338
Mobile: 07812 984 629
Email: simon.j.cooper@btinternet.com
Personal Profile
My main strengths arethe breadth and depth of my knowledge base, good concept-defining ability,adaptability and versatility,problem
solvingand trouble-shooting,responsibility,and attention to detail. At present I am hoping to find work that will truly test and develop the
attributes I have acquired and,hopefully,present me with new and more involved opportunities to further strengthen and diversi fy my
skills through everyday work and appropriatetraining. I amespecially interested in senior roles that would lead to management
responsibilitiesand / or Qualified Person training.
Work History
QA Officer at Vifor Pharma (Potters) / SFI Potters UK, Wigan. (September 2014 – September 2016).
Initially a 2 month contract, extended several times.
 Batch documentation initiation,reviewand approval.
 Internal audits.
 QA releaseof unlicensed herbal / VMS products and licensed herbal productintermediates.
 QA review, approval and releaseof artwork and packagingcomponents.
 Oversightof original deviation / CAPA systems.
 General supportof Warehouse, Production facility,Quality Control laboratory and quality systems to maintain compliancewith
GMP requirements and to help prepare for audits by regulatory authorities.
QC Analyst at PQ Silicas, Warrington. (April 2013 – September 2013)
3 month (extended to 6) short-term position created to deal with a back-logof work in the Central Analytical Department (CAD) laboratory,
involving:
 Wet chemistry analytical techniques and ion chromatography analysisfor the characterisation of a range of silica powder / gel
products.
 Sample receipt and distribution.
 Administration of equipment and SST logs.
 Data manipulation and inputonto a LIMS system.
 Adherence to auditschedules.
 Participation in laboratory self inspectionsfor safety and housekeeping.
Due to my extensive GMP experience I was also ableto give significantinputinto the planned and unplanned review of a number of
standard operatingprocedures and quality monitoringdata.
Quality Compliance Officer at Recipharm, Ashton-under-Lyne. (July 2010 – February 2012)
Originally a six month contractfor maternity cover, permanent position attained October 2010. Initially responsiblefor QA supportin dry
particleinhalers (DPI) and ointments & creams production areas (with some shared responsibility in others),subsequently partof a 3
person QA team in Steriles Department (cover for other production areas also provided as necessary) and finally,followingclosureof the
Sterile Products department in July 2011,I was the QA liaison for Stores and Engineering groups.
 General QA administrativeduties, under QP authorisation,such as:
 Document initiation,generation,review and approval.
 Quality systems administration (utilisingMAXIMO,SAP and Workbench systems).
 Internal auditor/external (customer and MHRA) audits as guide,scribeand back-roomsupport.
 Oversightof routine operations and general adviceon Complianceissues.
 Co-ordinatingprojects aimed at improvingthe sitecompliance,such as SOP revision,upgrades to existingservices and the
introduction of temperature and humidity control in GMP storage areas.
QA Administrator/ Technical Officer at INEOS HealthcareLtd (IHL), Warrington. (April 2007 – June 2010)
Initially as cover for maternity leave but awarded a permanent contractin January 2008.
 Responsiblefor the progression of batches of an investigational medicinal productfromthird party drug substancemanufacture,via
onsiteand third party QC analysis to third party drug product manufacture, and to eventual releasefor clinical trial use.
 Raw material approval, batch analysisreview, BMR review.
 Preparation and issuingof certificates of analysis for intermediate drug substance,final drugsubstance(API) and drug product
(tablets).
 GMP checks of IHL QC laboratory,GMP trainingfor all IHLCMC staff.
 Self-inspection / vendor audits.
 Preparation,review and issuingof GMP and GCP documentation.
 Administration of quality management system (change controls, deviations,OOS/OOT).
 Various laboratory validations includingcomputerised systems 21 CFR / annexe 11.

2. QA Officer at ChironVaccines (formerly Powderject Ltd), Liverpool. (March 2004 – July 2005)
 Jointly responsibility for the approval of training,facilities,equipment, raw materials,intermediates and products in the Formulation
department of the Fluvirin (purified surfacesub-unitinfluenza vaccine) production process. Skills / duties included:
 Gowning qualification required to access GradeB production areas where Grade A interventions were made under laminar air flow.
 Regular interaction with production,development, quality control and regulatory personnel.
 GMP oversightof the production process dealingwith routine and non-routine events. Routine work included verifyingcalculations
and documentation, maintenance of databases,collating,interpretingand disseminatingprocess information,and approval of
‘finished’lots on a SAP system.
 GMP inspections and auditing, and for all aspects of health and safety and COSHH.
 General and job specific inputinto design and installation of a revised process / refurbished department.
From November 2004 to March 2005 the Formulation department was re-designed and refurbished.I was involved in the design and
installation of the revised process,being ableto contribute through my knowledge of the process as a whole, my scientific expertiseand
my regulatory duties for that department.
Process Development Scientist at Powderject Ltd (formerly Celltech and Medeva Pharmaceuticals), Liverpool. (July 1999 – March
2004)
Initially employed as a microbiologistfor development department projects and any non-routine production issues.Subsequently retained
as partof manufacturing investigations and improvements team.
 Investigations into all aspects of the process,includingisolating,identifyingand quantifyingmicrobial contaminants where
necessary as an adjunctto routine QC testing.
 Reviewing and improvingproduction SOPs.
 Testing alternativeprocess reagents and equipment in lab-scaleset-ups of the process to provide alternatives / improvements to
the process.Data was collected,interpreted and disseminated as reports that were sometimes given as presentations.
 Testing alternativeprocess reagents and equipment in lab-scaleset-ups of the process to provide alternatives / improvements to
the process.
 Collating,interpretingand disseminatingdata as reports / presentations.
 Adherence to local procedures,health and safety, COSHH and risk assessments.
 Interaction and collaboration with Production,QC, QA, and other Development personnel.
 All development laboratory staff were trained in local procedures, health and safety, COSHH and risk assessment.The role required
closeinvolvement and collaboration with Production,QC, QA, and Development personnel.
Laboratory Analyst at QC (Compliance) Microbiology Laboratory, Eli Lilly, Liverpool. (December 1997 – June 1999)
Employed as partof an off-lineinvestigations group within the Microbiology Laboratory.
 Investigation of microbial excursionsin production areas.
 Preparation and revision of SOPs.
 Validation of new equipment, reagents or methods in the laboratory.
 Liaison with outsideagencies (such as validation consultantsor equipment engineers).
 Shift cover duringcertain production campaigns becauseof previous experience on endotoxin testing (firstnon-permanent member
of staff on site to do so).
Followinga sitere-organisation theoff-linegroup was reassigned and I was trained in all aspects of on-linetestingincluding:
 Water / process intermediate testing.
 Isolation,purification and identification of microbial contaminants.
 Preparation and maintenance of standard cultures.
Educational Achievements
Liverpool Polytechnic
BSc (Joint Honours) Class 2 (1)
 Applied Biochemistry and Microbiology

St Mary’s College, Crosby
‘A’ Levels:
 General Studies A
 Biology B
 Chemistry C
 Physics
‘O’ Levels (GCE):
 Six Grade A  Five Grade B  One Grade C
Interests& Additional Information
 I enjoy most sports and play rugby and 5-a-sidefootball regularly.
 I liketo socialisewith family, friends and colleagues,and enjoy goingto concerts,musical events, the theatre and the cinema.
 When circumstances permit,I enjoy keeping and breeding foreign and British birdsas well as tropical fish.
 I have started to expand a previously rudimentary interest in photography, having purchased a digital SLRcamera.
 I have a full drivinglicenceand havedriven a variety of cars and small commercial vehicles.

3. References
I can supply references from two of my most recent superiors on request