Compliance Documentation Owner

Compliance Documentation Owner Irvine, Scotland

GSK
Full Time Irvine, Scotland 29350 - 66576 GBP ANNUAL Today
Job description

Site Name: UK - North Ayrshire - Irvine
Posted Date: May 19 2023


CLOSING DATE:
2nd June 2023

  • The role will be offered as a 12-month Secondment or Fixed Term Contract for the purpose of maternity cover.

GSK make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2022.

We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.

We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.

The Compliance Document Owner will provide ownership of all GMP documentation related issues within Quality, Technical, Engineering, Commercial and Operations areas, ensuring compliance with Regulatory and GSK requirements thereby protecting the patient and helping the site to achieve our goals.

In this role you will…

  • Co-ordinate and administrate updates to GMP documents including but not limited to, local standard operating procedures (LSOPs), Methods and Specifications, Standard Work Instructions (SWIs), Isolation Work packs, Logbooks and Batch Manufacturing records within the Quality, Technical, Engineering, Commercial and Operations departments
  • Manage the document workflow within either the document management system, Veeva Quality Docs or through the use of file shares
  • Ensure current ways of working and any future changes to the document control processes are well communicated and understood across the site, including training to relevant LSOP, document and file share owners
  • Monitor and report against a series of agreed document management measures and KPIs
  • Support, monitor and continually improve the site systems associated with document control and to fully engage with GPS to deliver improvements
  • Prepare any necessary documentation in respect of site document control processes and records management to support site audit requirements

Why you?

Minimum Qualifications & Skills:

  • HNC in Administration or IT or suitable experience in an appropriate discipline within a pharmaceutical environment
  • Experienced user of computer system applications, preferably in document management e.g. VQD
  • Good analytical skills and excellent attention to detail
  • Ability to work according to global standards related to the role
  • Strong planning and organisation skills
  • Good communication skills and customer focus experience

Preferred Qualifications & Skills:

  • HNC in Business Administration specialising in Information Technology
  • Expertise in document administration and information management
  • Excellent MS Office skills

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. 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 [email protected] 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.

Compliance Documentation Owner
GSK

www.gsk.com
Brentford, United Kingdom
Emma Walmsley
$10+ billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
1830
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