GSK
Pharmaceutical Manufacturing
QualityManager(onShift)
Neural analysis suggests this role is
optimal for Manager candidates.
“Quality Manager (on Shift) at GSK. Skills: Quality Assurance, GMP Compliance, Process Management. Monitor quality related systems. Ensure products released meet requirements”
What You'll Achieve.
Ensure products conform to registered requirements; Ensure products conform to regulatory requirements; Ensure products manufactured to cGMP
Industry & Context.
Deviation investigation; Root cause analysis
Work in GMP area, Shift work
What They're Looking For.
Must Have
BSc in Scientific, Technical or Engineering discipline, Equivalent experience in Pharmaceutical Manufacturing, Knowledge of current Good Manufacturing Practice requirements, Knowledge and application of Quality Management Systems
What You'll Do.
Monitor quality related systems
Ensure products released meet requirements
Assess and record impact on product quality
Ensure products conform to requirements
Liaise with other functions on incidents
remediate and investigate deviations
Review/endorse CAPA proposals
Provide Quality approval of GMP procedures
Participate in management monitoring of Quality processes
Support value stream management monitoring activities
Provide support in investigation of customer complaints
Provide support in investigation of vendor complaints
Identify potential quality issues
Ensure process changes are controlled
Assess and monitor impacts of process changes
Ensure product released conforms to standards
Provide quality oversight of facilities
Provide quality oversight of equipment
Provide quality oversight of personnel
Support Distribution Risk Assessments
Coach staff in quality standards
Coach staff in compliance standards
Provide quality guidance through TAP process
Provide quality guidance through Gembas
Provide quality guidance through quality meetings
Promote team working across Ware site
Promote effective communication across Ware site
Promote team working across GSK Quality functions
Promote effective communication across GSK Quality functions
How You'll Work.
Team & Collaboration
Liaise with other functions; Cross-functional coordination; Work with production teams; Work with operations teams; Liaise with supported functions; Quality assurance team; Wider Quality functions
Communication Scope
Verbal communication; Written communication
Full Job Description
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 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 a Quality Operations Manager, the Quality Manager on Shift (Operational QA) ensures that activities related to both manufacturing and non-manufacturing areas are carried out compliantly with SOPs and GMP and the impact on product quality and supporting quality systems is fully assessed and recorded. Ensure that products that are released and distributed to market conform to registered and regulatory requirements and are manufactured to cGMP. **Key Responsibilities:** * To liaise with other functions as appropriate in dealing with incidents affecting product quality or compliance, ensuring that deviations from GMP, specifications or company standards are fully recorded, remediated and investigated. * To include the review/endorsement of CAPA proposals and to provide Quality approval of GMP procedures and documents. * Participate in management monitoring of Quality processes and support wider value stream management monitoring activities. * Provide necessary support in the investigation of customer or vendor complaints. * Identify potential quality issues within manufacturing/packing/warehouse operations or other non-manufacturing areas as appropriate (via inspection, GEMBA and process confirmation). * Ensure manufacturing, packaging, Warehouse and wider support process changes are controlled appropriately and the impacts adequately assessed and monitored. * Ensuring that product released/shipped conforms to the required quality standards. * Provide quality
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