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Employer Pe Global
Job Title Compliance Specialist
Description

PE Global is currently recruiting for a Compliance Specialist for a client site in Cork -

Job Description

A Compliance Specialist conducts regulatory examinations and internal audits across the organization. They conduct periodic compliance reviews of departments, ensuring that procedures and guidelines are met. They prepare documentation of internal procedures utilizing state and federal rules, regulations, statutes and other third-party compliance resources. A Compliance Specialist prepares compliance manuals and programs, develops compliance training modules and training of compliance team members, and performs due diligence visits and risk assessments. They also deal with non-routine tasks and confidential information. Works with moderate work direction and is skilled and knowledgeable to the position.

Provide change control support for the manufacture and testing of clinical and commercial biologics, vaccines and small molecules Drug substance and Drug products (cross modality).

Change Control activities include:

  • Position will involve progressing and reviewing change control documentation from all areas on site.
  • Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision.
  • When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, for the most efficient way of progressing proposed change with minimum disruption to the site.
  • Review change control documentation received for clarity, ensuring relevant supportive data has/ will be generated.
  • Confirm categorisation of site change control
  • Establish productive working relationships with colleagues within project teams at site and other regulatory / change control subsidiaries.
  • Link in with site Change Owners in terms of what change control would need to be reviewed by CMC regulatory personnel to determine impact to Clinical / commercial licenses for proposed changes.
  • Provide Change control support as required during HA inspections
  • Provide change control training to the site for change originators and reviewers of proposed changes
  • Leverage off the network in terms of change control guidance and support for biologics and vaccines when required.
  • Provide guidance and support to the site in terms of change control business processes and systems
  • Support the application and management of site licenses and GMP certificates.
  • Update manufacturing authorization to ensure that site documentation is in line with approved registrations.
  • Carry out annual product reviews from Change Control Perspective
  • Project management skills

Requirements:

  • Degree in Biological Sciences, Biochemical engineering or related discipline. Advanced degree preferred
  • Good analytical skills and systems awareness, high level of data gathering, process mapping and financial. Knowledge of SOX Compliance
  • Min 3-5 Years biological experience -Regulatory / Technical / QA experience in biological research , development and / or manufacturing

If interested please send CV to Audrey - audrey.brennan@peglobal.net or call 0214297900

This job originally appeared on RecruitIreland.com
Location Cork
Date Added 8 days ago
Apply Link
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