External Label Specialist
2 weeks ago
Posted Date: May
About the role
External Label Specialist within Global Pack Management is responsible for the creation and approval of label content for third parties for the following modalities:
- Vaccines
- Pharmaceuticals (supplies packed external to GSK)
The External Label Specialist will liaise with the Clinical Interface/CTSM teams to create the label content and liaise with multiple third party manufacturing/ packaging companies to create and approve the final GSK Clinical Trial labels, using GSK Systems such as SMART LS and Prisym.
The approved labels will be used for labeling clinical trial supplies packaged at third parties. In addition, the role will have opportunity to cross train in a number of additional areas within GPM.
About the responsibilities
- Work within a global team, create master label content according to existing processes and procedures specific to each modality
- Liaise with third party contract manufacturing/packaging companies to provide label content and receive labels created by the third parties
- Perform quality critical checks of label content produced in various languages within the required timelines
- Creation of label documentation, required for in-country regulatory submissions, in a timely manner
- Liaise with third party service provider of country approvals (regulatory intelligence)
- Identify opportunities for process improvement
- Ensure quality right first time across all elements of the label creation process
- Participate in quality investigation activities (Root Cause Analysis, Product Impact Assessment, Mitigation Action definition)
- Participate in corrective and preventive actions (CAPAs)
- Motivated to self-assign core tasks, prioritizing and completing as part of a wider team with minimal supervision/ input
- Work with external vendors, such as translation service provider and third party clinical trial label approvers
- Participate in department improvement projects
- Participate in GPM team meetings
- Liaise with other groups within Clinical Supply Chain such as Clinical Interface/CTSM and Quality Assurance
About you
- Master degree or bachelor with at least 5 years of experience
- Understanding of cGMP requirements and regulatory requirements
- Proficient in Microsoft package and Adobe tools
- Ability to work between multiple GMP IT software systems, adapt to changing systems
- Ability to follow written instructions
- Ability to work effectively with others to meet timelines, business goals and objectives.
- Excellent verbal and written skills
- Ability to work individually as well as part of a team
- Ability to challenge the status quo
- Capacity to work in a cross-cultural environment
- Perfect fluency in English
#GSKVaccines
#LI-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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