Senior Quality Specialist

1 week ago


London, UK, United Kingdom Talent Works Full time

Senior Quality Specialist

12-month contract

Hybrid – 3 days in London

Global pharmaceutical company


Job Description

The Senior Quality Specialist works with a high degree of independence, while providing oversight of the development, implementation and maintenance of relevant quality initiatives in support of their function.

They are adept at troubleshooting problems, coordinating and executing activities on multiple complex projects ensuring alignment with corporate goals and compliance with all regulatory requirements.


Key Responsibilities:

  • Perform disposition activities for Finished Goods in support of Clinical/Commercial Product, including:
  • Master and Executed Batch Record review and resolution of comments/issues
  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
  • Certificate of Analysis approval
  • Status change in Oracle
  • Archiving of batch documents in electronic document system
  • Collaborative reviewer of internal procedures
  • Support quality oversight of artwork/label review, approval, & implementation
  • Provides quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
  • Provide quality support for planning of product launches and tracking of new artworks
  • Assist in packaging validation activities as needed
  • Develops relationships with strategic external partners in support of expanding commercial portfolio and assist with ongoing relationships.
  • QP Relationship and Release
  • Facilitate Disposition of QP Release of finished goods
  • Assist with QP Declaration requests
  • Collaborative reviewer of internal procedures
  • Establishment of Quality Processes/Process Ownership – Packaging /Labeling and QP Release of Finished Goods
  • Serve as review/approver or owner of deviations
  • Monitors and trends events and identifies/proposes corrective actions
  • May serve as CAPA owner
  • Identifies risks and communicates gaps to management
  • Assists with the generation of process related metrics/monitors for efficiency
  • Commercial Change Control
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, strategy for GMP release and disposition strategy
  • Maintain batch disposition spreadsheets, input data and extract metrics.


Key Requirements:

  • Relevant degree
  • Good communication skills and ability to engage with internal and external stakeholders
  • Demonstrated ability to work independently to provide QA support for relevant projects
  • Skilled in creating and maintaining spreadsheets in Excel, including the use of formulas and macros
  • Knowledge of global GMP/GDP requirements governing oral drug products including exemption management and non-licence supply.
  • Knowledge of packaging and labelling process and artwork requirements
  • Investigation and Root Cause Analysis tools/methodology
  • Audit process understanding
  • Ability to assess when to escalate urgent requests
  • Ability to take ownership and accountability for shared information



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