Operations Compliance Specialist

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Employee Value Proposition

Overview:

Reporting to the Inspection Readiness Lead, the
Operations Compliance Specialist is responsible for all aspects of
Documentation Management & Compliance.

Requirements

Responsibilities:

Document Management

• Manage the authoring & drafting of all types of
  Manufacturing Operations documentation.
  
• Specifications & associated forms in conjunction with
  the various departmental subject matter experts (SME)
  
• Support document updates and manage timelines for cross
  functional Projects.
  
• Act as a SME/Superuser on the Controlled Document System
  to facilitate the processing & approval of documents.
  
• Organise & Facilitate Document Round Table meetings
  with cross functional teams as required
  
• Mange and build Quality Veeva QMS metrics for
  Manufacturing Operations
  
• Coach & Train colleagues in Documentation System
  & GDP queries
  
• Support manufacturing operations on meeting deadlines on
  Veeva QMS records
  
• Update compliance procedures and processes.
  

Compliance Tasks

• Generate Reports/Metrics & analyze trends as required
  including but not limited to:
  
• Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC
  metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics.
  
• Perform Logbook Training, review, and trending of all
  closed logbooks, identifying issues and managing timely archiving.
  
• Train and perform Area Self Inspections & Generate
  ASI schedule.
  
• Train Manufacturing colleagues in GDP/GMP
  
• Management of Veeva paper Binders
  
• Continuous monitoring of Compliance in Manufacturing.
  
• Facilitate all internal and external Inspections.
  
• Participate in permanent inspection readiness by
  completing Inspection walkthroughs within manufacturing operations.
  
  

Additional tasks:

• Collaborating with Global colleagues (as required)
  including but not limited to: Supplier Change Notifications, EDMS &
  Managerial Data Management
  
• Management of Job Descriptions & New Hire Checklist
  and Assigning Lockers.
  
• Be proactive & collaborative in troubleshooting &
  resolving issues with documentation, training & systems collaborating with
  different departments across the site.
  
• Engage in Continuous Improvement Initiatives
  
• Manage compliance projects and Inspection readiness
  updates.
  
• Apply aligned Operations Compliance Specialist role
  skills across Drug Substance, Drug Product and Packaging.
  

Requirements:

• 2+ years’ experience in technical writing and compliance
  
• Proficient in data analytics, data visualization
  
• Working knowledge in Regulations, GMP, GDP
  
• 2+ working within a regulated healthcare industry
  including a role in capacity of quality and compliance.
  
• Strong verbal, written and oral communication skills.
  
• Able to work independently and be flexible to changing
  priorities