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Quality Manager
3 months ago
The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at the GSK Ware Manufacturing Site. This entails monitoring all quality related systems, improvement procedures and documentation (including analytical data and information), ensuring that products released have been manufactured, packaged and distributed according to all Regulatory and cGMP requirements (including appropriate certification for EU markets).
Job Purpose:
Reporting to the Supplier Quality and Customer Complaints Manager, you will be responsible for managing/approving customer complaints to ensure complaints are investigated and reported in line with regulatory requirements. You will manage site-based supplier quality operations to ensure materials being delivered to site are of the appropriate quality.
Key Responsibilities:
Approve Customer Complaint responses and assess atypicality. Escalation of atypicality to stream Operational Quality. Tracking completion of complaint investigations to meet required timelines. Progress Customer Complaint investigations including logging complaints, monitoring of progress, assessment of findings and documentation of outcomes. Working with other sites to drive standardisation of customer complaints process Regular updates and communication to LOCs regarding progression of complaints. Provision of weekly and monthly complaint reports to stakeholders. Act as the key liaison between the Ware site and assigned suppliers, incorporating central supplier quality, procurement and audit teams as required, for supplier quality matters. Where change controls are required, coordinate the on-site activities for supplier and outsourced service provider change controls. Assess new and existing suppliers / service providers via desktop assessment or audit to ensure they are suitable to carry out activities. Collate and review supplier quality history data and prepare reports to determine level of acceptability based on risk. Investigate and manage vendor complaints, including informing the supplier; ensuring they understand and accept the issue; working with them to address root causes; generating effective CAPA and confirm acceptability of supplier responses. Approve supplier agreements in consultation with relevant departments and suppliers. Collate Customer complaint and supplier data required for inclusion on PPRs. Assess critical metrics for suppliers and ensure written agreements in place for outsourced activities covering required GMP requirements and that these are reviewed according to required schedule. Act as SME/inspection lead for Supplier Quality management or Customer Complaints during internal and external audits ensuring that processes are robust and inspection ready at all times. Lead self-inspections. Work alongside central functions (Procurement, Global Supplier Quality, Logistics etc.) by supporting requests such as pre-audit info, customer complaint trends, supplier quality performance reviews etc. Ensure any site issues are escalated through such teams to drive resolution.About You:
As this role is multi-faceted and includes liaising with a wide variety of on-site production teams, above-site stakeholders and external suppliers you will be a self-motivated individual who has strong experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.
About Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products.
CLOSING DATE for applications: Tuesday 11th of June 2024 (COB).
Basic Qualifications:
Degree in relevant Scientific, Technical or Engineering discipline Relevant quality-related experience gained from working in a highly-regulated industry (eg; Pharmaceutical Manufacturing Facility) Knowledge of current Good Manufacturing Practice requirements. Knowledge and application of the principles of the Quality Management Systems (QMS).Benefits:
GSK offers a range of benefits to its employees, which include, but are not limited to:
Competitive base Salary Annual bonus based on company performance Opportunities to partake in on the job training courses Opportunities to attend and partake in industry conferences Opportunities for support for professional development/chartership Access to healthcare and wellbeing programmes Employee recognition programmes Hybrid (onsite/remote) working within GSK policies (post training period)If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage .
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.
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.
