GSK

Pharmaceutical Manufacturing

QualityManager(onShift)

£75–110k ~AI est. United Kingdom FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Pharmaceutical Manufacturing
Problems you'll solve

Deviation investigation; Root cause analysis

Eligibility Requirements

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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