Labware LIMS Data Technician required to help transfer technical data into Laboratory Information Management System.
Skills
LIMS software commercial experience.
BSc or equivalent in Pharmaceutical Analysis, Computer Science, life Sciences or related.
SQL knowledge.
GMP laboratory experience
Role
Configure, maintaining, and migrating LIMS data
Support Chemistry laboratory as needed.
Labware LIMS Data Technician required to help transfer technical data into Laboratory Information Management System.
Skills
LIMS software commercial experience.
BSc or equivalent in Pharmaceutical Analysis, Computer Science, life Sciences or related.
SQL knowledge.
GMP laboratory experience
Role
Configure, maintaining, and migrating LIMS data
Support Chemistry laboratory as needed.
Statistical SAS Programmer required to join a team supporting multiple clinical and non clinical studies, particularly focusing on regulatory submissions. The ideal candidate will be an expert in Study Data Tabulation Model, Analysis Data Model, and other CDISC standards.
Skills
BSc or higher in Computer Science, Mathematics or related subject.
SAS programming within the pharmaceutical industry, with a focus on clinical trials.
Familiarity with regulatory submissions, including associated industry guidance and the application of SDTM and ADaM CDISC standards.
CRT or Case Report Tabulation and define.xml standards.
Developing or managing CRT tools.
Role
Program and validate SDTM datasets, including complex efficacy and lab data, and other clinical outputs.
Technical expert in SDTM, ADaM, and other CDISC standards. Provide consultancy, advice, and training to the team.
Program complex non efficacy outputs and figures, perform senior review, and deliver quality control of non statistical outputs.
Comply with regulatory guidelines and requirements, particularly related to CDISC standards, GCP (Good Clinical Practice), and clinical trial documentation.....Read more...
Statistical SAS Programmer required to join a team supporting multiple clinical and non clinical studies, particularly focusing on regulatory submissions. The ideal candidate will be an expert in Study Data Tabulation Model, Analysis Data Model, and other CDISC standards.
Skills
BSc or higher in Computer Science, Mathematics or related subject.
SAS programming within the pharmaceutical industry, with a focus on clinical trials.
Familiarity with regulatory submissions, including associated industry guidance and the application of SDTM and ADaM CDISC standards.
CRT or Case Report Tabulation and define.xml standards.
Developing or managing CRT tools.
Role
Program and validate SDTM datasets, including complex efficacy and lab data, and other clinical outputs.
Technical expert in SDTM, ADaM, and other CDISC standards. Provide consultancy, advice, and training to the team.
Program complex non efficacy outputs and figures, perform senior review, and deliver quality control of non statistical outputs.
Comply with regulatory guidelines and requirements, particularly related to CDISC standards, GCP (Good Clinical Practice), and clinical trial documentation.....Read more...
The Regulatory International Operations organization spans over ten Pfizer offices in more than seven time zones. Each year the group supports approximately 40,000 submissions to 175 countries around the world, within both established and emerging markets. The group operates in a dynamic business environment and is a key contributor in ensuring quality dossiers are submitted on time to Health Authorities for the Pfizer portfolio. The Global Registrations & Renewal Support (GRRS) team are a team of operational experts that sit under Regulatory International Operations.
The GRRS team has a strong continuous improvement, project management and change management focus. The team specializes in sourcing Regulatory certificates and samples for the Emerging Market submissions while constantly evaluating and redesigning existing regulatory and operational processes. The team also perform cross-functional critical issue remediation and lead project/change management initiatives at a global scale.
As the Pharmaceutical Industry evolves Regulatory Operations act as a key stakeholders in the innovation, design, and implementation of new technical solutions, process designs and deployment through the global teams and networks.
Job Responsibilities:
This role will support initiatives of varying complexity, for which Regulatory Operations is either an owner or a major stakeholder.
The GRRS apprentice will:
Work in a busy, diverse regulatory environment developing critical business skills and be a valued member of a multidisciplinary team
Day-to-day delivery of regulatory certificates & product samples, working closely with senior leaders of the organisation
Logistics coordination:
Contribute to and manage global projects which aim to drive growth, improve business process and overall consolidate Pfizer’s position as the premier pharmaceutical company. Typical projects can include working on business transformation, building new capabilities, increasing business efficiency, re-designing complex processes or program management efforts in the regulatory operations arena
Partner with internal & external colleagues to support the operation and evaluation of existing processes, driving continuous improvement, learning and applying a variety of continuous improvement tools and methodologies
Main duties and Responsibilities:
Support business analysis and project management efforts to assist in ensuring the success of a broad variety of global initiatives and projects
Issue resolution and escalation for assigned projects
Recognise and analyze potential issues and provide a systematic approach to the solutions of these issues while noting any practical constraints
Contribute business solutions through influential partnerships with internal and external colleagues
Act as a key contributor within the areas of process development, decision making, and change management in the context of regulatory operations
Support cross-functional, global teams as appropriate
Develop and maintain documented procedures and guidelines as necessary
Support in future recruitment of Undergraduates and/or apprentices
Training:
Training for this apprenticeship will be completed online
Training Outcome:
Upon successful completion of the apprenticeship, you will be eligible to apply for other positions within the business
Employer Description:As the specialists in skills for science and technology, our purpose is to make sure your business; your people and our industry are future ready. We are a not-for-profit charitable organisation with a family of commercially focused companies committed to supporting the skills, needs and ambitions across the UK science and technology sector.Working Hours :Monday - Thursday, 9.00am - 5.25pm, Friday, 9.00am - 4.05pmSkills: Communication skills,IT skills,Attention to detail,Organisation skills,Presentation skills,Administrative skills,Analytical skills,Logical,Team working,Creative,Initiative,Patience....Read more...
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We’re deeply committed to our strategy of being a great place to work. For us, that includes fostering an environment where everyone can be among inclusive, supportive individuals with curious minds
A company that genuinely follows the science and values individuals at all levels, you’ll be backed and encouraged to speak up, ask questions, and share ideas to push the boundaries of science and continuously learn and explore
As part of our Early Talent Programme, you’ll be involved in projects and learning opportunities that have real impact from day one
Being part of our journey and helping us to provide life changing medicine to patients all over the world and transform lives for the better
Making important contributions and embracing our values to deliver on our purpose. Because regardless of role or level, we all have an important part to play in making a positive difference.
The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. The Quality Supplier Management Apprentice role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.
As a Quality Supplier Management (QSM) Apprentice, you will support the Quality team in ensuring that our external suppliers meet the standards needed to safely and effectively develop AstraZeneca (AZ) medicines. You will learn how quality oversight works and play an important role in helping maintain AZ’s reputation for high-quality science and product development.
In this role, you will:
Work alongside project and sourcing teams to learn how to use science‑based risk management to identify potential quality issues and help develop practical solutions.
Support the Quality Supplier Management activities related to the development, manufacture, testing, release, and distribution of Drug Substance, Drug Product, and Investigational Medicinal Products for clinical trials.
Help monitor and improve supplier performance by applying the Quality Supplier Management Lifecycle under guidance from experienced colleagues.
Build strong working relationships and develop your scientific understanding of the products and processes you will be supporting.
AstraZeneca will sponsor you through your Laboratory Scientist Degree Apprenticeship including studying to complete a BSc (Hons) degree in Bioscience at Manchester Metropolitan University https://www.mmu.ac.uk/study/apprenticeships/courses/scientist-bioscience
The apprenticeship combines working, earning a full-time salary, with fully funded part-time university learning (on average 1 day/week). This will give you the opportunity to gain a qualification, just as you would if you went to university full-time, with the advantage of gaining relevant work-life skills and the excitement of helping to develop new medicines whilst taking your first steps towards a rewarding career
Additionally, the apprenticeships are recognised by the relevant professional bodies at Registered Scientist (RSci) level, for which there is a requirement that the scientist will participate in subsequent continuing professional development on completion of the apprenticeship
We truly value Early Talent - their thoughts, ideas and contributions. So throughout the programme, you’ll be encouraged and inspired to speak up, have a voice and make an impact
Training:
Apprentices work full-time whilst studying towards a BSc (Hons) Bioscience degree from Manchester Metropolitan University, as well as a Level 6 degree apprenticeship
Students study a tutor-supported e-distance learning curriculum and attend residential schools. The work-based projects, negotiated with employers, offer students the opportunityto apply their learning directly to their organisation
The programme is primarily taught through tutor-supported online study, part-time over four years
Apprentices will attend a two-day induction at the University to help them get to know each other and balance undergraduate study with working full-time
They will also attend a week-long residential at our campus in central Manchester once a year, in addition to a two day mini-residential in the first year
Training Outcome:
On successful completion of the apprenticeship, candidates will be able to apply for further positions
Employer Description:At AstraZeneca we believe in the potential of our people and as an apprentice you will be given the opportunity to develop beyond your wildest dreams. We are looking for people who can share our passion for science & technology so if you feel you have the drive and determination to help us to deliver first class medicines to meet the needs of patients around the world, then we invite you to apply.
Our scientific research, development and technological innovation is well respected in the industry and we support our people, helping them to go above and beyond their expectations.
As a global, science-led biopharmaceutical business, our focus is on creating and developing new medicines that make a meaningful difference to patients’ lives and the UK is at the heart of our efforts to do that.Working Hours :Monday - Friday, shifts to be confirmedSkills: Communication skills,Organisation skills,Problem solving skills,Number skills,Analytical skills,Logical,Team working,Initiative,Literacy skills,Self-motivated,Work independently....Read more...
