QA Manager

Job Ref: J34054
Sector: Science
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 08 November 2019
  • England, UK UK DE15 0YZ
  • £40,000 - £50,000 per Annum
    ANNUM
  • Balbir Panesar
  • 0121 728 8455
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QA Manager

Permanent

East Midlands

Competitive salary & package

Do you have QA experience? Have you got experience of managing a small team?

Role:

  • Lead the Quality Assurance team to ensure compliant and efficient operation of the following systems/processes:
  • Quality Management System
  • Document Control
  • Corrective/Preventative Action system
  • Internal Audit process and program (including mock recalls)
  • Management Review - preparation of data / metrics
  • Quality process monitoring - oversight and maintenance of tracking systems for all quality-critical processes
  • Customer technical agreements
  • Annual Product Quality Reviews
  • Data integrity - oversight and maintenance of site Data Integrity Log and associated risk assessments
  • Horizon Scanning*Site validation, calibration and equipment maintenance
  • Equipment qualification and associated process validation
  • Cleaning validation & cross-contamination risk assessments
  • Management of the site Validation Master Plan
  • Bulk, clean and dirty hold time validation
  • Site pest control program
  • External audit management
  • Customer / third-party audits
  • Regulatory inspections
  • Management of samples for regulatory surveillance
  • Supplier Management
  • API declarations & excipient risk assessments
  • Supplier selection, qualification and auditing
  • Supplier performance reviews
  • Supply Chain mapping
  • Control of transportation suppliers
  • Promote a culture of continual improvement within the team and wider company by:
  • Championing root cause analysis and use of appropriate risk management tools throughout all activities.
  • Coaching others to help them understand how their day-to-day activities relate to the Quality Policy and Quality Objectives.
  • Ensuring that all processes and working practices within your area of responsibility are constantly reviewed and any compliance or efficiency improvements are implemented in a timely fashion proportional to the risks identified.
  • Ensure all procedures relating to the systems you are responsible for are kept up-to-date and reflect both internal and external best practices.
  • Lead and develop your team by:
  • Ensuring adherence of both you and your team to Health and Safety, Good Manufacturing Practice and other relevant guidelines and legal obligations.
  • Ensuring all team members are adequately trained and supported in the performance of their duties and responsibilities.
  • Coaching team members to understand their own performance and how it relates to company performance and their own career development.
  • Managing individual and team contributions to ensure goals and performance targets are met.
  • Supporting team members to develop their skills and functional expertise.
  • Act as a subject matter expert within your area(s) of functional expertise both for your team and the wider organisation.
  • Ensure the customer's expectations (both implicit and explicit) are embedded throughout all activities.

Key requirements:

  • The ability to lead, motivate and manage a team,
  • Excellent attention to detail,
  • Analytical and problem-solving abilities,
  • Detailed knowledge of root cause analysis and risk management tools and their application,
  • Good understanding of applicable regulations, standards and best practices,
  • Good communication, interpersonal and influencing skills,
  • Good numerical skills and the ability to handle and analyse data,
  • Sound knowledge of data analysis tools (e.g. Excel, Minitab etc.),
  • The ability to present complex information (both internally and externally) to diverse audiences and levels of understanding,
  • Planning and project management skills.

If you're interested in the role, please make an application online or alternatively contact me on 0121 728 8455 should you have any questions.

SRG
08/12/2019 16:50:13
GBP 40000 40000