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Posted Date: Aug 16 2023
Batch Release Specialist
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
As a Batch Release Specialist, you will be preparing dossiers for the batch verification of medical devices or medicinal products. This will involve reviewing batch deviations, change controls and test results.
Key Responsibilities include, but are not limited to:
- Liaise with External Quality, Sites, Manufacturers, and other groups for co-ordination of batch verification.
- Support the Medical Device Regulatory Compliance Manager or Qualified Persons in compliant batch review and ensure timely escalation of any issues identified,
- Review associated records and documentation, including deviations, changes and tests.
- Raise and investigate deviations relating to medical devices processes including batch verification.
- Conduct activities to support Quality Systems (including ISO 13485) including:
- Quality meetings
- Deviation management
- Customer Complaint and Adverse Event/Serious Adverse Event management and trending
- Key performance indicators generation and reporting
- SOP / Technical report preparation and approval
- Conduct/participate in audits / self-inspections
- Periodic Product Reviews
- Processes effectiveness checks
- Ensure batches verified are maintained, and dossiers and samples archived in accordance with local SOPs and GMP/GDP/MDR 2017/745 requirements.
- Effectively communicate with Supply Chain Hubs, Local Operating Companies, manufacturing sites, External Supply managers and other stakeholders in the business.
- Present data on GSK’s behalf during regulatory inspections of importation operations.
Closing Date for Applications: 30th August 2023 COB.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Educated to GCSE/A Level standard (or equivalent). May hold a degree in a relevant science subject.
- Experienced in manufacturing site operations, batch record review, quality data review and operational quality requirements.
- Understanding of quality management principles.
- Capable of working in multi-disciplinary teams across IT, Quality, External Supply, Global Logistics, Supply Chain and Manufacturing.
- Working knowledge of medical device, GMP and GDP regulations.
- Able to present on aspects of the medical device certification process where role holder has responsibility during regulatory inspections.
- Experienced in application of GPS thinking and tools and knowledge of performance measures
- Demonstrated experience of quality documentation review.
- Knowledge and experience of self-inspection processes and participation experience.
- Good oral and written communication skills. Ability to problem-solve. Ability to work to deadlines.
Preferred qualifications:
- Understanding of ISO 13485 compliance.
- Experience of using systems such as Veeva Quality Doc and Veeva QMS and Team Sites.
#LI-GSK
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
