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Quality Operations Manager

WALKER COLE INTERNATIONAL LTD
Job LocationLondon
EducationNot Mentioned
Salary50,000 - 55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

KEY RESPONSIBILITIES

  • To schedule and manage the Quality Operations Team with responsibility for resource allocation, day to day objectives setting, appraisals and staff performance management.
  • Managing the batch review process ensuring timely batch review and release
  • Ensure review of all Quality and production batch documentation is completed correctly, to achieve an elevated level of service and GMDP
  • In addition to direct line management duties the post holder is expected to develop the skill sets within the team. Enhancing team and inter departmental interactions within the business whilst motivating the group to deliver an effective and compliantservice to operations.
  • Ensure operational metrics are provided to agreed time scales and to provide performance measures for the PQS to the Head of Quality.
  • Provide QA support to the business during root cause analysis investigations.
  • Drive the performance of the Pharmaceutical Quality System across the business.
  • Work with the Head of Quality to optimize QA performance and drive continuous improvement.
  • Ensure daily issues are addressed and raised in a timely manner.
  • Support activities required to effectively maintain the company Pharmaceutical Quality System.
  • Ensure resources are available to monitor alerts for potential overdues for Complaints, CAPA, GDP issues, Deviation and Change Control.
  • Support and represent the business during regulatory and customer audits.
  • Sets performance objectives/goals for quality operations team and regularly evaluate employees performance.
  • Ensure Key Performance Indicators (KPI) are established and maintained.
  • Manage and perform GEMBA walks on a frequent basis to monitor the housekeeping practices in the area and to evaluate GMDP and DI compliance.
KEY ACCOUNTABILITIES AND DELIVERABLES
  • Ensure operational EQMS tasks are efficiently managed.
  • Drive site compliance standards using appropriate metrics with respect to the timely completion of quality records to meet agreed performance targets.
  • Promote a dynamic and committed site quality culture through the performance management of the PQS
  • Implement management and control initiatives to mitigate or eliminate overdues records across the site.
  • Provide and analyse trend data to identify and address quality deficiencies.
  • Participate in internal and external audits.
  • Participate in reviews of OOS and RCAs in a timely manner and timely escalations to HOQ/QP as required.
  • Evidence timely collaborating with relevant stakeholders to achieve timely completion of all CAPAs relating to customer audits and Internal self-inspection.
  • Evidence of timely completion of ad hoc and other tasks as assigned.
  • Report writing as required

Keyskills :
GMPOperationsQuality AssuranceManagerQMS

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