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Es-DE-30646
Junior Read more about levels here
Data Analyst Pound Rate: £485
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Foundation
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Data Architect
Pound655
Industries
Health Care Health Care Industrial Industrial Pharmaceutical Pharmaceutical
Projects
Business and Process Optimisation Business and Process Optimisation Regulatory Change Regulatory Change
About me

Determined, highly self motivated, proactive and enthusiastic professional with +7 years of experience in the ATMPs and pharmaceutical industry working with protein and cell based products.

Have a wealth of information about the drug process development in the field of biopharmaceutical, transferring technology to production scale, and the requirements for licensing drugs.

The last 3 years of my career have been in Pharmaceutical Industry where I have developed experience and skills related to GMP-based Implementation of new projects and Quality Systems Management

A team player with strong analytical abilities and a ‘can do’ attitude. Ability to manage multiple priorities with strict timelines. Experience in analytical and technical problem-solving.

Superpowers
Quality Management Regulatory Compliance
Skills
Quality AssuranceQuality ManagementRegulatory Compliance
Experience
Sep, 2022
Current
laboratory and quality manager
Health CareHealth Care
Laboratory and Quality
This candidate has extensive experience in managing and developing quality systems, procedures and processes. They have demonstrated success in developing a conceptual framework for quality measurement and improvement activities across multiple clinic sites, and summarizing findings in the annual Quality Improvement (QI) Plan. They have also successfully ensured laboratories work within current GLP, and have conducted method validation of clinical biochemistry and hematology instruments in accordance with EP15/A2.
Key responsibilities Key responsibilities
  • Developing quality systems and procedures
  • Creating conceptual frameworks for quality measurement
  • Ensuring laboratories work within GLP
  • Conducting method validation of clinical instruments
Key achievements Key achievements
  • Developing QI Plan
  • Summarizing findings in QI Plan
  • Successfully ensuring laboratories work within GLP
  • Conducting method validation of clinical instruments
Sep, 2021
Jul, 2022
care quality and regulatory consultant
Health CareHealth Care
Care quality and regulatory
Provided quality processes for a company to meet CQC registration requirements, including writing and reviewing the quality system and creating a URS for a facility. Ensured compliance with regulations and standards to maintain quality and safety of the services provided.
Key responsibilities Key responsibilities
  • Write and review quality system
  • Create URS for facility
  • Ensure compliance with regulations
  • Maintain quality and safety
Key achievements Key achievements
  • CQC registration requirements met
  • Quality processes implemented
  • Regulations and standards adhered to
  • Services provided safely and effectively
Aug, 2020
Aug, 2021
qualified person
PharmaceuticalPharmaceutical
Quality Control
Highly experienced Quality Control Manager with extensive experience in delivering significant improvements in QC and product sciences capabilities, efficiency, throughput and compliance. Skilled at writing protocols, reports, SOPs and testing documents. Experienced in leading, organizing and managing laboratory functions such as equipment, compliance investigation and personnel issues. Proven ability to manage QC work, both for short-term turnaround and ongoing projects. Represented QC department at management meetings, collaborating with QA, Production and other departments.
Key responsibilities Key responsibilities
  • Writing protocols and reports
  • Managing laboratory functions
  • Leading and organizing QC work
  • Representing QC department
Key achievements Key achievements
  • Improving QC and product sciences capabilities
  • Increasing efficiency, throughput and compliance
  • Managing QC work for short-term and ongoing projects
  • Collaborating with other departments
Aug, 2019
Aug, 2020
plant manager
IndustrialIndustrial
Manufacturing
Efficiently managed programs and projects to drive significant improvements in quality control, product science capabilities, efficiency, throughput and compliance. Wrote protocols, reports, SOPs and testing documents. Ensured laboratories followed GXP regulations. Led, organized and managed laboratory functions, such as equipment, compliance investigation and personnel issues, including performance management, absence management and development. Organized the management of QC work.
Key responsibilities Key responsibilities
  • Managing programs and projects
  • Writing protocols and documents
  • Ensuring GXP regulations
  • Leading laboratory functions
Key achievements Key achievements
  • Improving quality control
  • Increasing product science capabilities
  • Increasing efficiency and throughput
  • Maintaining compliance
Feb, 2019
Aug, 2019
quality control manager
Health CareHealth Care
Quality control
Provided significant improvements in quality control and product sciences capabilities, efficiency, throughput and compliance. Wrote protocols, reports, SOPs and testing documents. Ensured analytical methods and procedures were in place and followed consistently. Led, organised and managed laboratory functions such as equipment, compliance investigation and personnel issues. Organised the management of QC work for short-term turnaround and ongoing projects.
Key responsibilities Key responsibilities
  • Wrote protocols, reports, SOPs and testing documents
  • Ensured analytical methods and procedures were followed
  • Led, organised and managed laboratory functions
  • Organised the management of QC work
Key achievements Key achievements
  • Significant improvements in quality control and product sciences capabilities
  • Increased efficiency, throughput and compliance
  • Ensured consistency in analytical methods and procedures
  • Managed laboratory functions effectively
Apr, 2018
Feb, 2019
quality assurance manager
PharmaceuticalPharmaceutical
Quality Assurance
Quality Assurance Manager responsible for supervising all activities and staff of the facility, ensuring compliance to all relevant Quality Standards and regulatory requirements, managing lot release process, initiating improvements to the Quality Management System, and preparing and issuing certificates of compliance and certificates of analysis. Led product lifecycle documentation requirements, participated in process verification and technical transfer projects, and evaluated environmental monitoring results.
Key responsibilities Key responsibilities
  • Supervising activities and staff
  • Ensuring compliance to standards
  • Managing lot release process
  • Improving Quality Management System
Key achievements Key achievements
  • Led product lifecycle documentation
  • Participated in process verification
  • Evaluated environmental monitoring results
  • Issued certificates of compliance and analysis
Feb, 2017
Apr, 2018
quality control manager
Health CareHealth Care
Quality Assurance
A Quality Control Manager with expertise in validating analytical methods, developing specifications and testing processes for raw materials, establishing user requirements for purchase and qualification of QC analytical equipment and generating CoAs for product release. Adept at working with internal and external resources to maintain optimal equipment state and reviewing proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
Key responsibilities Key responsibilities
  • Validate analytical methods
  • Develop specifications and testing processes
  • Establish user requirements for purchase and qualification of QC analytical equipment
  • Generate CoAs for product release
Key achievements Key achievements
  • Work with internal and external resources to maintain optimal equipment state
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies
  • Manage quality control processes
  • Ensure compliance with company standards
Jan, 2015
Feb, 2017
quality control analyst
Health CareHealth Care
Quality Control
Quality Control Analyst responsible for ensuring the safety and purity of cell based products. Conducted sterility testing, gene expression analysis, telomerase activity tests and mycoplasma detection to ensure product suitability. Ensured raw materials were used correctly and met release criteria for cell therapy production. Utilised Molecular Biology and Genetics Laboratory to analyse biological products.
Key responsibilities Key responsibilities
  • Ensuring safety and purity of cell based products
  • Conducting sterility testing
  • Analyzing gene expression
  • Performing telomerase activity tests
Key achievements Key achievements
  • Ensuring raw materials met release criteria
  • Utilizing Molecular Biology and Genetics Laboratory
  • Analyzing biological products
  • Detecting mycoplasma