Purpose
To assist Quality Lead (Systems) and Manager (Compliance and Systems) in the management and administration of quality systems in line with GSK standards and cGMP regulatory requirements. Quality systems include document management, training compliance, archival, etc.
Key Responsibilities Area
- Process Owner for document archival system on site.
- Maintain QA oversight of documents archived on-site and off-site
- Provide QA consultation and troubleshoot on document archival related issues.
- Ensure that all deviations / change controls are closed or assessed for impact on archival system
- Review / Author of SOPs related to document archival
- Perform annual system review for effectiveness and implement actions accordingly
- Process owner for GMP training system on site, as assigned
- Maintain QA oversight of documents archived on-site and off-site
- Maintain QA oversight of the processes for Training and perform governance checks on executed Training Change Request (TCR)
- Support management of electronic tracking system (PIER, myLearning).
- Manage site training metrics reporting.
- Provide QA consultation on GMP training related issues
Skills, Knowledge & Experience
Professional
- Minimum University Degree in a Science or Engineering discipline
- Minimum 3 years' experience within the pharmaceutical industry
- Experience in pharmaceutical industry in GMP regulated areas is preferred.
Technical
- User experience with SAP will be preferred.
- Good knowledge of quality management systems
- An extensive understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing.
- Ability in handling and organizing multiple workflows
- Ability to understand the functionalities of systems and link with usage capabilities
Business
- Understanding of regulatory compliance issue
- Good interpersonal and communication skills
- Good facilitation and presentation skills
- Good organizational skills
- Ability to apply optimal quality assurance standards to promote a business edge
- Ability to facilitate and influence business activities compatible to international regulatory environment
- Ability to communicate effectively within the site organization and across the network
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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.
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