Site Name:
UK - Hertfordshire - Ware Posted Date:
Jan 28 2025 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 manage site-based supplier quality operations to ensure materials being delivered to site are of the appropriate quality. The role also has responsibility for managing/approving customer complaints to ensure complaints are investigated and reported in line with regulatory requirements. 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. 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). CLOSING DATE for applications: Wednesday 12th of February 2025 (COB).
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UK - Hertfordshire - Ware Posted Date:
Jan 28 2025 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 manage site-based supplier quality operations to ensure materials being delivered to site are of the appropriate quality. The role also has responsibility for managing/approving customer complaints to ensure complaints are investigated and reported in line with regulatory requirements. 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. 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). CLOSING DATE for applications: Wednesday 12th of February 2025 (COB).
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