Compliance Leader

Job type:
Real Staffing
flag_no United Kingdom
project ID:

This project is archived and not active any more.
You will find vacant projects in our project database.
You will ensure all quality relevant site documentation is controlled and managed as per regulatory requirements and to internal company standards.

Key Accountabilities:
  • Ensures systems are in place to issue, control, periodically review, obsolete and archive all quality relevant site quality documentation.
  • Manages the transition to a new documentation system as part the development of the quality system for the company of the future.
  • Is the Subject Matter expert on the site electronic Quality systems - Mango, Trackwise and eDMS as appropriate.
  • Ensures the site complaint and deviation investigation systems work effectively to predefined timelines.
  • Supports and supervises Risk Analysis and assessments; acts as a moderator as necessary.
  • Works with the QC Manager to ensure QC systems are integrated in to the site quality systems.
  • Ensures electronic systems are validated according to Merck and GAMP requirements.
  • Support business in GxP and internal audits.
  • Develops and reports KPIs to measure improving performance of the quality assurance system.
  • Develops actions together with the business for improving KPIs and general quality standard.
  • Supports, classifies and supervises Change Controls.
  • Supports, assesses and closes Deviations.
  • Provides and facilitates training on quality.
  • Supports NPD and extensions to current product portfolios where appropriate.

Essential criteria
  • Hold relevant science degree
  • Substantial experience in a QA management role
  • Previous experience as Lead Auditor and experience of auditing

Desirable Criteria
  • Previous experience in a liquid manufacturing environment
  • Previous experience of compiling PQRs
  • Experience of delivering training
  • Risk management experience

This is a great opportunity to be a part of a multi national organisation with huge scope to progress in your career.

If you are interested in the position please send an updated CV to Jade Tetlow or call for further details I would be happy to discuss.

We also offer £200 for all referrals

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