Summary
Overview
Work history
Education
Skills
Timeline
Generic

Dagmara Miles

Stevenage,Herefordshire

Summary

Diligent Quality Associate with 5 years of experience in Pharmaceutical Quality Assurance. Attentive quality assurance professional offers proven history of success in quality-focused environments. Excels in fast-paced and dynamic roles with precise time management. Strong command of quality standards and reporting processes.

I hold a master's degree in environmental engineering and have experience of working in Laboratory/fieldwork relating to this discipline. I am conscientious and hard-working person with a ‘glass half full' attitude. For the last 5 years I worked in pharmaceutical industry where I have gained great organisational and problem-solving skills and logical, objective thinking, along with a keen eye for detail. I thrive in fast paced environments and works well whilst under pressure. I constantly want to develop and learn new skills, whilst utilising my previous skills and knowledge

Overview

12
12
years of professional experience

Work history

QA Associate

Achilles Therapeutics
Stevenage, Hertfordshire
07.2023 - Current
  • Support operational QA duties to ensure GxP Compliance and with regulatory requirements relating to the manufacturing, QC testing and conduct of clinical trials
  • Support the administration of the Company’s Document Management System
  • QA Review and approval of procedures, master batch records, and any other relevant cGMP documentation
  • Perform batch documentation review activities
  • Review Standard Operating Procedures (SOPs) to ensure compliance with cGMP and other relevant regulatory requirements
  • Support, review and approve Change Controls, Non-Conformances and CAPAs
  • Provide Manufacturing and Quality Control Functions with QA Support
  • Review and approve Out of Specification investigations
  • Work with teams across the business and externally to investigate quality issues
  • Support complaints management process and where appropriate respond to complaint investigations
  • Support with any qualification & validation activities
  • Support the QA Manager with hosting customer audits and regulatory inspections
  • Support of provision of In-house training activities
  • Provide Support and data for Achilles Quality Management Reviews
  • Designer and point of contact for personnel GMP Training.


QMS Document Controller

Freeline Therapeutics
Stevenage, Hertfordshire
01.2019 - 07.2023
  • Organising and maintaining documents, adhering to the company's documents lifecycle procedures and archiving inactive records in accordance with the record retention schedule.
  • Receiving and processing requests for information from employees or clients.
  • Assisting with file migration and audits, and perform administrative tasks as needed.
  • Review, issue and control all QA-Controlled Documents, including but not limited to : Quality Manual, Policies, SOPs, Validation Master Plans, Site Master File, Batch Manufacturing Records, Certificates of Analysis.
  • Issue controlled copies of PQS controlled documents, including but not limited to batch manufacturing records, environmental monitoring sheets, validation protocols, calibration forms.
  • Issue and control of GxP logbooks and QC lab Notebooks.
  • Ensuring that all QA documentation is appropriately stored in the fire-proof safe.
  • Ensuring that authorised copies of approved documents are available to personnel. Ensuring that all relevant personnel are notified when new PQS Documents are published.
  • Ensuring that superseded and withdrawn documentation is securely stored and is no longer accessible to non-QA personnel.
  • Maintaining and updating logs of QA controlled documents.
  • Assigning reference numbers to PQS documentation and quality incident, including but not limited to: SOPs, Change Controls, Deviations, QIEs, Audits, QTAs, Specifications, RMSs.
  • Issuing reference copies of controlled documents, ensuring their return and destruction when they are no longer effective.
  • Preparation and issue of in-process labels.
  • Preparation of KPIs.
  • Contributed to accurate and efficient document quality checks, ensuring error-free results.
  • Stored documents using cloud-based systems to drive efficiencies.
  • Established archiving, issuing and reconciliation of QA-controlled documents, authored relevant Standard Operating Procedures ensuring appropriate training is enrolled.

Quality Auditor

Kolak Snackfood
Stevenage, Hertfordshire
05.2018 - 01.2019
  • Ensuring that standards of excellence are maintained during production of goods.
  • Conducting tests on a product (level of oil, level of moisture, level of flavour etc.).
  • Performing inspections of raw materials, manufactured components and finished products.
  • Inspecting and calibrating auditing tools such as scales and other testing equipment.
  • Preparing technical reports.
  • Audited existing operational practices, proactively challenging and implementing improvement to ensure compliance and growth.

Food and beverage supervisor

Exclusive Hotels and Venues Fanhams Hall
Ware, Hertfordshire
05.2014 - 05.2018
  • Scheduling and managing employees.
  • Training of new joiners in food regulatory compliance and company standards by delivering on-the-job and mandatory training.
  • Inspiring staff to deliver a prompt, friendly and efficient service at all times.
  • Overseeing food and beverage inventory, strategically ordering supplies and anticipating consumer demands to prevent out-of-stock items.
  • Resolving customer complaints regarding food quality and service and making sure the business complies with health and food safety regulations.
  • Managed restaurant, bar and banqueting operations on shift basis, catering up to 300 guests at any one time.
  • Reconciled cash and credit card transactions to maintain accurate records.
  • Planning staff rotas to meet customer demand whilst remaining under budget.
  • Coordinated Front of House and Back of House staff ahead of events for smooth execution to maximise guest satisfaction.

Physical Worker

Oojevar-Ham Holding
05.2013 - 09.2013
  • Taking care of irrigational systems (cleaning, service, maintenance), deciding - according to needs of the crops - about the dose of the irrigation.
  • Caring for plants, including pruning, pest scouting, weeding, tying, thinning and tucking.
  • Taking part in harvesting operations using tractors, harvesters, forklifts and hand tools.
  • Planting ground crops between rows of trees and bushes to control weeds and soil temperatures.

Telemarketer

CBB Call Centre
01.2013 - 05.2013
  • Selling products via telephone (such as educational books for children, hardware).
  • Describing the product benefits and special offers.
  • Giving advice about how these may benefit customers personally.
  • Persuading customers to accept a trial period or a visit from a sales representative.
  • Entering notes into a computer, including dates for follow up calls.
  • Taking an order and arranging for delivery of goods and preparing invoices.
  • Conducting market research or satisfaction surveys after a sale has been completed or a complaint has been made.
  • Resolved customer complaints by escalating calls to proper department.
  • Logged call details and customer information in secure systems, improving data collection measures.
  • Achieved daily performance targets, aiding department progression towards sales goals.

Biotechnical laboratory worker

Communal Sewage Farm
06.2012 - 09.2012
  • Performing laboratory tests to produce reliable and precise data to support scientific investigations.
  • Carrying out routine tasks accurately and following strict methodologies to carry out analyses.
  • Maintaining and operating standard laboratory equipment, for example centrifuges, titrators, pipetting machines and pH meters.
  • Ensuring the laboratory is well-stocked and resourced. Using computers and performing mathematical calculations for the preparation of graphs.
  • Calibrated laboratory tool and equipment for accurate research outcomes.
  • Supported senior technicians with experiment design and planning.
  • Following and ensuring strict safety procedures and safety checks.

Education

Certified First Aider : Health and Safety -

St John Ambulance
Stevenage, Hertfordshire
/2022 -

Certificate: Biotechnology for Non-Biotechnologist -

Management Forum
Online
/2022 -

Health and Safety Certificate Level 2 -

Qualifi Ltd
Online
/2020 -

Master of Science: Environmental Engineering - Ecological Engineering

Agricultural University
Krakow, Poland
06.2014 -

Skills

  • Drivers licence, cat B
  • Computer literate with all Microsoft applications (Office, Visio) with good typing speed
  • Quality documents control expertise
  • Good Documentation Practice compliance
  • Quality investigations
  • Batch record reviews
  • Risk Assessment
  • Risk mitigation
  • Compliance management
  • Outstanding organisation under pressure
  • Resource ordering
  • Excellent motivator and team player
  • Possess good telephone and excellent customer service skills Effective communicator, both written and verbal

Timeline

QA Associate

Achilles Therapeutics
07.2023 - Current

QMS Document Controller

Freeline Therapeutics
01.2019 - 07.2023

Quality Auditor

Kolak Snackfood
05.2018 - 01.2019

Master of Science: Environmental Engineering - Ecological Engineering

Agricultural University
06.2014 -

Food and beverage supervisor

Exclusive Hotels and Venues Fanhams Hall
05.2014 - 05.2018

Physical Worker

Oojevar-Ham Holding
05.2013 - 09.2013

Telemarketer

CBB Call Centre
01.2013 - 05.2013

Biotechnical laboratory worker

Communal Sewage Farm
06.2012 - 09.2012

Certified First Aider : Health and Safety -

St John Ambulance
/2022 -

Certificate: Biotechnology for Non-Biotechnologist -

Management Forum
/2022 -

Health and Safety Certificate Level 2 -

Qualifi Ltd
/2020 -

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Dagmara Miles