Label Specialist
4 weeks ago
The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. I order to deliver medicine to patients in clinical trials the patient kit need to have a translated and regulatory compliant label. The label development is business critical and linked to overall delivery and approval of clinical trials. Frequently the label development activities are on the business-critical path for study set-up and start.
**Accountabilities / Responsibilities**
The Label specialist will support wider Supply Chain organization via development of translated and regulatory compliant study labels using SmartSupplies LRA (Label Routing and Approval) module and LRA process. This includes activities related to new regulatory requirements for labels and identification of new base phrases in SmartSupplies LRA and support of overall label development process improvements. The Specialist must work according to label regulations (i.e. Annex 6) and Good Manufacturing Practice (GMP) standards.
The Label Specialist will support Clinical Study Supply Leads (CSSLs) in label development and change management. This will include:
- Cooperate with CSSLs to convert supply chain study design in to label requirements
- Act on behalf of CSSL during translation activities with external vendor
- Author/review/approve Study Master label document/Label templates and label approval forms
In addition, as part of a wider Label Specialist Network, contribute to:
- Establishing best practice and ensure issues and learnings are shared both locally and globally
- Support senior roles within the team in development and improvement of the LRA processes, SOPs, guides, instructions and training materials associated with label development
- Perform updates to LRA database (country requirements and translations)
- Deliver Label guidance to CSSLs
**Essential**
The Label Specialist will require technical understanding of both the business processes and the label technologies associated with clinical supply. Further key capabilities required for this role include: Change enablement; Flexibility/adaptability; Commitment to customers and integrity, and Works Collaboratively.
This role will impact the speed, quality, cost and risk profile of development projects and the overall portfolio and impact the availability of study drug to patients. As such, it has potential to significant the financial and reputational impact dimensions of AstraZeneca.
**Education, qualifications, skills, experience and capabilities**:
- University degree
- Strong computing skills
- Excellent English skills - verbally and written
- Proven analytical and strategic thinking
- Demonstration of problem solving skills
- Demonstration of high attention to detail
- Ability to learn new information effectively
- Flexibility to react to different customer needs
- Multi-language skills are a merit
**Label Specialist** role will require:
- Deep and technical understanding of both: business processes and label technologies associated with clinical study supply.
- Change enablement.
- Flexibility/adaptability.
- Strategic leadership.
- Commitment to customers and integrity.
- Working collaboratively.
-
Label Specialist
1 month ago
Macclesfield, United Kingdom AstraZeneca Full timeThe Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. I order to deliver medicine to patients in clinical trials the patient kit need to have a translated and regulatory compliant label. The label development is business critical and linked to overall delivery and approval of clinical trials....
-
Quality Assurance Specialist
1 month ago
Macclesfield, United Kingdom CK GROUP Full timeCK Group are recruiting for a Quality Assurance Specialist to join a company in the Pharmaceutical industry at their site based in Macclesfield on a contract basis for 12 months. You will need to be on site for a minimum of 3 days a week.**Hourly/Daily Rate**: £270 (Umb) / £250 (PAYE). **Hours of Work**: 5 days / 36.5 hour a week. **Essential...
-
Quality Assurance Specialist
1 month ago
Macclesfield, United Kingdom CK GROUP Full timeCK Group are recruiting for a Quality Assurance Specialist to join a company in the Pharmaceutical industry at their site based in Macclesfield on a contract basis for 12 months. You will need to be on site for a minimum of 3 days a week. **Daily Rate**: £270 (Umb) / £250 (PAYE). **Hours of Work**: 5 days / 36.5 hour a week. **Essential Requirements**: -...
-
Global Safety Data Sheet Specialist
1 month ago
Macclesfield, United Kingdom AstraZeneca Full time**Global Safety Data Sheet Specialist** **Location**: Macclesfield UK and Sweden - Sodertalje and Gothenburg Competitive salary and benefits package **Astrazeneca policy on hybrid working is average of 3 days in the office** **About AstraZeneca** As one of the world's leading pharmaceutical companies, our business is focused on providing innovative,...
-
Automotive Health and Safety Specialist
2 weeks ago
Macclesfield, Cheshire, United Kingdom Eurofins PSS Ireland Ltd Full timeEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies...
-
Health and Safety Specialist
5 days ago
Macclesfield, Cheshire, United Kingdom Eurofins PSS Ireland Ltd Full timeEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest...
-
Health and Safety Trainee Specialist
7 days ago
Macclesfield, Cheshire, United Kingdom Eurofins PSS Ireland Ltd Full timeEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest...