Amanda Doherty Email & Phone Number

Bathgate, Scotland, United Kingdom

Bathgate

Providing support for QP team at Bathgate and support to assist the QPs in their daily duties.• Generate and review Quality Technical Agreements, Supply Chain documents.• Attend study set up meetings, Change of Scope, Client calls to assist with the assessment of supply chains and provide guidance on the QP certification requirements.• Manage and co-ordinate the receipt of documentation pertaining to complex supply chains. Access to multiple internal and Client share point sites to download and upload files where appropriate.• Review of storage and distribution receipts for Final Products received at BTH (Quality Assurance)• Review and approve Drug product specifications used by QC (Quality Control)• Perform Quality approval functions for investigations/deviations, complaints and change controls, liaising with the QPs and the Client to monitor audit dates and close out observations.• Participate in the internal audit program – Walk through audits.• Assist in the assessment of new EU GMP requirements, including Supporting Brexit/Cross dock activities - creating QP declarations, attending meetings, creation and update of trackers, collating and sharing of documents.• Control of Product specification files, checking/verifying, filing and archiving.• Monthly toggl report downloads for QP team/ upload of QP billing hours onto JDE (JD Edwards V9.1) electronic inventory system• Creation and upkeep of various trackers including QP review tracker and genealogy trackers.• Continuous Improvement: Passed (December)Business Improvement Techniques course (West Lothian College): including safety, teamworking, visual management, 5S, problem solving techniques, Kaizen.• STEM representative for Catalent (Clinical trials, Industry and Chemistry).• Value award winner for assisting with planning and trackers• Leading First Aid for Mental Health (ST Andrew’s First Aid), certified 19Oct2021

Bathgate

• Providing QA presence, GMP checks, live time problem solving, live checks on documentation/ packaging exercises, batch notes and support within both the packaging and warehouse areas.• Events and deviation sign off as Quality Assurance SME for Packaging and Clinical storage areas and participating on the DME Daily Rota.• Verification and release of Special Projects, Temperature excursion report QA sign off.• QA Review and Release of Final Product: Storage and Distribution supplies. Batch Record Pre-reviews.

Performing QA Line Audits, Critical Control Point Audits, Listeria GMP Audits. Product and Facility Temperature Checks, Line Checks – ensuring Line checkers performance and documentation of their quality checks (weights, metal detection, products on line and product Labelling are correct). Checks on Oven and Blast Chill records.• Calibration of temperature probes, inline scales, offline scales and air probe for pack checks. Quality Investigations into any issues, Allergy testing, Final Product check, 40 pack weight checks. • HACCP Level 2 attained, trained in Listeria awareness and in Allergen Management.

Pentlands Science Park

• Sole responsibility for stability suite, stability reports, all stability studies and the Stability and Release Analysis of Proteins/Antibodies.• Method development and Validation of Reverse Phase and Size Exclusion HPLC methods.• Preparation/checking of reports - Pre-Validation & Validation Protocols/Reports, SOPs, Stability Protocols, Material specifications, COSHH/ BioCOSHH assessments, Deviation and Event reporting.Stability Analysis of Proteins/Antibodies. Analysis included SEC-HPLC, SDS-Page, ELISA, UV A280, pH and Appearance.

Dalry North Ayrshire

• Testing of effluents, raw materials (including tanker samples), In Process Control samples, Stability samples and Final Products for manufacture of Vitamin C.• Checking of Peers results, LIMS & SAP/R3 data entry/approval. Instrument calibrations.Analysis includes HPLC, GC, HLGC, headspace GC, KF, manual and automatic titrations, pH, turbidity, conductivity, density, UV, total solids, LOD, sulphated ash, heavy metals, whiteness testing.

• Testing of Inks, Toners and Dyes, Instrument Calibrations, Stock control/ordering.• Continuous improvement: complete overhaul of documentation storage and sample storage areas - Individual project. • LIMS data entry and investigations.Analysis included FPIA, Coulter, DSC, Capillary Rheometer, halogen drier and HPLC. Instrument calibrations also include pH meters, balances, UV spectrometer and instruments used for analysis as before.

Stirling

• Testing of solid and liquid dose forms. Analysis included HPLC, dissolution, disintegration, FTIR, UV, LOD, appearance, average weight, uniformity of weight.

Glasgow, Scotland, United Kingdom

• Analysis of sterile samples received by the QC Laboratory.• Provision of analytical support to Production and Clients•Calibration of instruments including HPLC and FTIR•Liasing with Development group allowing transfer of analytical methods•Ensuring correct receipt, labelling, storage, dispatch of samples•Review of testing results and reports from peers•Working to cGMP•Identifing OOS and OOT failures and reprting these to line management•Writing of SOPs, Protocols and Reports•Liasing with internal and external ClientsTrend analytical data over time•Analysis included HPLC, FTIR, pH, Appearance, osmolality

Riccarton, Edinburgh

• Performance testing of Inhalation Products and their active pharmaceutical ingredients. Also capsules, tablets, liquids and suspensions.• Deputised/acted as Supervisor- responsibility for Stability time point and standalone projects including preparation of protocols, scheduling of Analysts time/Analysis required/Equipment, customer updates.• Preparation and updates to documents including Protocols, Specifications, SOPs, COSHH, Material Specifications, Validation Protocols and Reports for Instruments and Analysis. • The assignment of the training and awareness levels, for colleagues, on the SOP/COSHH/Safe working instruction forms. Member of Safety and housekeeping team.• Checking and verifying of Peers analytical write ups, results, reports and Laboratory Investigations as Supervisor.• Actively taken part in multiple Kaizen Blitzes (Lean Sigma) - improvement of the laboratory and later archiving in preparation of transfer to Aptuit Verona.• Training of peers in various analytical techniques and use of equipment ensuring analysis performed consistently to GMP/GLP standards.• Different Clients awarded multiple Certificates to the Respiratory Technology team.• Possess Crawford Scientific certificates for Fundamental HPLC, Troubleshooting/Maintenance and Method development courses - passed with distinction.Analysis included HPLC, KF, UV, Dusa, Anderson Cascade Impaction, New Generation Impaction.

• Performing routine analysis on final products, active and non-active intermediates and raw materials.• LIMS/SAP data entry and approval. Checking and verifying of Peers analytical write ups and results.• Training of others in HPLC, Raw materials testing, site water testing and maintenance of water units.• Creation/improvements of SOPs. Deviation and Event reporting.• Member of Method review /improvement team: resulting in cost savings.• Member of safety/housekeeping committee.• Actively taken part in multiple Kaizen Blitzes (Lean Sigma) including improvement of sample storage.Water analysis (including TOC)Classical analysis (including TLC, Karl Fischer, FTIR, UV)HPLC analysis

• Methods including BP, EP & USP methods and techniques (NAMAS accredited laboratory) UV and FTIR SpectrophotometryThin Layer ChromatographyPhysical testing (including Disintegration and Dissolution)Member of Safety and house keeping committee

• Environmental - wet chemistry techniques and reports. Organic Synthesis – Synthesis of CatalystsIntroduction to the Chemical IndustryDevelopment of written presentation skillsUsing a wide range of standard chemical methodsPreparation of novel and heterogeneous catalysts for organic synthesis, with H2O2 as the main oxidantInvestigation into the rate of destruction of H2O2 in the presence of metal salts.Evaluation of industrial waste water samples for pollutant concentrations and H2O2 effectivenessMember of Safety and house keeping committeePrevious to these dates I had weekend jobs in the retail industry all of which involved dealing closely with the public in a position of trust. The employment also entailed individual and teamwork in the interest of security and appearance of the working surroundings.

B.Sc, Pure Chemistry

Electives include Pharmaceutical Studies & Drug Development, Introduction to Environmental Health, Management Science 1 and Introduction.

Revised Highers, Chemistry; Physics, Maths And English, Higher Art

Standard Grades in Modern Studies, French and Office and Information studies. Scotvec modules in Introduction to computers/computer.