- Support the Creation, Maintenance and Continuous Improvement of Achilles Quality Management System (QMS) Ensuring Compliance with Regulatory Requirements
- Perform Operational QA Duties to Ensure GxP Compliance and Regulatory Requirements Relating to the Manufacturing and Conduct of Clinical Trials
- Support the Administration of the Company's Document Management System
- Perform 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 GMP and Other Relevant Regulatory Requirements
- Review and Approval of Change Controls
- Work with teams across the business and externally to maintain compliance with both Achilles QMS and Catapult's QMS in a multi-tenant manufacturing facility
- Support Operational Functions with Review and Approval of Deviation Investigations, Ensuring Effective Root Cause Analysis
- Ensure that Deviations, CAPAs, Protocols/Reports and Other Applicable Documents are Approved Within the Designated Timelines.
- Review and Approve Out of Specification Investigations
- Work with Teams Across the Business and Externally to Investigate Quality Issues
- Issue and Review Corrective and Preventative Actions (CA/PAs)
- Support Complaints Management Process and Where Appropriate Respond to Complaint Investigations
- Support with Any Qualification & Validation Activities
- Provide Advice and Guidance to the Wider Team with Support from the QA Manager
- Perform Internal Audits to Determine Compliance with GMP and Identify Areas for Improvement
- Perform External Audits as Necessary
- Support the QA Manager with Hosting Customer Audits and Regulatory Inspections
- Support Senior Management with the Co-ordination of Recall Activities
- Support of Provision of In-house Training Activities
- Provide Support and Data for Achilles Quality Management Reviews
- Experience working in QA in a Biotech/Biologics/ATMP GMP Environment - Ideally on MIA /MIA IMP Licensed Site
- Technical Knowledge of Aseptic Manufacturing Processes, Sterility Assurance and Laboratory Techniques
- Thorough Understanding of EU and US GMP Requirements
- Experience within a GMP Quality Assurance Department
- Experience Investigating Deviations, Complaints, Reviewing Change Controls, Implementing CAPAs and Conducting Internal Audits
- Experience with Batch and Associated Documentation and its Review
- Understanding of Clinical Trial Directives/Regulations
- Knowledge about Regulatory Requirements for ATIMPs
- Experience with Environmental Monitoring
- Experiences with Clean Rooms
- Experience in a QC GMP Environment
- Experience with Equipment Qualification Activities
- Experience with Validation Plans, Activities and Reports
- Experience of Working with Sponsors, Contract Manufacturing Organisations and Contract Testing Laboratories
- Experience with Document Preparation/Review in Support of Regulatory Submission Packages
- Experience Conducting External Audits
- Knowledge on HTA Requirements for Cells and Tissues
-
Associate Gmp Production Scientist
2 days ago
Achilles Therapeutics London, United KingdomAchilles is a fast paced, trail blazing company. We are breaking new ground with our science creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organ ...
-
QA Associate, GMP
2 weeks ago
Achilles Therapeutics Limited United KingdomAchilles is a fast paced, trail blazing company. We are breaking new ground with our science creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organ ...
-
Senior QA Associate, GMP
1 week ago
Achilles Therapeutics Limited United KingdomAchilles is a fast paced, trail blazing bio-technology company focussed on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer company. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and Univ ...
-
Associate Qc Scientist
1 week ago
Autolus Ltd Stevenage, United KingdomWe are currently looking for an Associate QC Scientist or QC Scientist to join our Bioassay QC Team based at our Cell Manufacturing site in Stevenage. Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed t ...
-
Associate Qc Scientist
1 week ago
Autolus Ltd Stevenage, United KingdomQuality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product ...
-
Associate Qc Scientist
1 week ago
Autolus Stevenage, United Kingdom**Location**: · - Stevenage**Job Summary**: · Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow to monitor and drive the manufacturing processes, release the product or ...
-
Senior QA
21 hours ago
BioTalent Stevenage, United KingdomI have an exclusive opportunity for a **Senior QA Associate** to join a pioneering biotechnology company based in **Stevenage** that focuses on developing T-cell therapies for cancer treatment. · They seek a Senior QA Associate with GMP experience to support their manufacturing s ...
-
QA Team Lead
1 week ago
Rentschler Biopharma SE Stevenage, United KingdomRentschler Biopharma ist ein führendes Auftragsentwicklungs · - und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die ...
-
Associate Research Scientist
2 days ago
Thermo Fisher Scientific Stevenage, United KingdomAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide ou ...
-
Senior Regulatory Affairs Officer
1 week ago
Blackfield Associates Hertfordshire, United KingdomAre you a Senior Officer/ Associate looking for further progression? · Would you like more responsibility for strategic development? · My client has an exciting opportunity for you; we are looking for a Senior Regulatory Affairs Officer CMC, to join an independent business in Her ...
-
Multi-skilled Technician
1 week ago
Hyper Recruitment Solutions Ltd Hertfordshire, United KingdomAre you a Multi-Skilled Engineering Technician with a background working within a manufacturing or production environment? If so, we have an exciting new opportunity for a Multi-Skilled Engineer to join a leading Pharmaceutical manufacturing company basedin the Hertfordshire area ...
-
Quality Systems Administrator
31 minutes ago
Clinical Professionals Hatfield, United Kingdom**Reference Number: JO ** · Quality Systems Administrator · Rate: Negotiable · **Job Type**: Permanent · Location: Hatfield · Quality Systems Administrator · Permanent · Hatfield · Cpl Life Sciences are currently partnering with a global pharmaceutical company that supports with ...
-
Assistant Therapy Area Marketing Lead
1 week ago
Viatris Hatfield, United Kingdom7540 Viatris UK Healthcare · At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. · Viatris empowers people worldwide to live healthier at every stage o ...
-
Assistant Therapy Area Marketing Lead
1 week ago
Viatris Hatfield, United Kingdom7540 Viatris UK Healthcare · At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. · Viatris empowers people worldwide to live healthier at every stage o ...
-
Therapy Area Marketing Lead
1 week ago
Viatris Hatfield, United Kingdom7540 Viatris UK Healthcare · At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. · Viatris empowers people worldwide to live healthier at every stage o ...
-
Small Molecule Drug Substance Lead
21 hours ago
GSK Ware, United Kingdom**Site Name**: Singapore - Jurong, Cork, Irvine, Montrose, Stevenage, USA - Massachusetts - Boston, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence, Ware, Worthing · **Posted Date**: Apr · **_ Purpose_**: · The Global Manufacturing Science and Technology (MS ...
-
Shift Co-ordinator
2 days ago
GSK Ware, United Kingdom**Site Name**: UK - Hertfordshire - Ware · **Posted Date**: Apr · GSK's Manufacturing Site at Ware has an opportunity available for a Shift Co-Ordinator in our Micronising facility. The Micronising team is responsible for performing all tasks associated with particle size reduct ...
-
Team Leader, Dpd
31 minutes ago
GSK Ware, United Kingdom**Site Name**: UK - Hertfordshire - Ware RD · **Posted Date**: Jan · **Team Leader, DPD - Oral & Inhaled, UK** · Are you interested in the opportunity to lead and shape product development for our global medicines while leading a team? If so, this Team Leader, Drug Product Devel ...
-
QA Associate
21 hours ago
Hyper Recruitment Solutions Ltd Cambridgeshire, United KingdomI'm currently looking for a QA Associate for a 12 month FTC to join a leading Pharmaceutical business based in the Cambridgeshire region. This role has the potential to turn into a permanent position Some of your duties will be as follows: · KEY DUTIES AND RESPONSIBILITIES: · You ...
-
Packing Operative/packer
2 days ago
The Recruitment Crowd (Yorkshire) Ltd Dunstable, United Kingdom**Packing Operative/Packer** · **The Recruitment Crowd have recently partnered with a market leading client who are looking to expand their multi-skilled team** · **Pay Rate**:£11.75 p/h · **Hours**:Monday to Friday 6am-2pm · **Location**: Dunstable, LU5 · **Job Type**: Temp to p ...
Senior QA Associate, GMP - Stevenage, United Kingdom - Achilles Therapeutics
Description
Achilles is a fast paced, trail blazing bio-technology company focussed on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer company. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and University College London (UCL), we use DNA sequencing data from each patient, together with our proprietary PELEUSTM bioinformatics platform, to identify clonal neoantigens specific to that patient. From this, we develop personalised T cell therapies and currently have two programmes in the clinic for the treatment of Lung Cancer and Metastatic Malignant Melanoma.
As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach runs through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy making sense of ambiguity and thrive on making things happen even when there is not a detailed brief.
Role Summary:
We are seeking a Senior Associate to primarily perform and support QA duties at a manufacturing site for Achilles product (Investigational Medicinal Product), thereby ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained. The role will also support the separate Achilles Quality Management System, ensuring activities conform to regulatory requirements.
Responsibilities:
Requirements
Essential:
Desirable:
Benefits
This is a permanent role, offering a competitive benefits package
At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot
Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.
