Title Compliance Systems Specialist
Categories Career
Job Summary

Compliance Specialist is responsible for administering GMP computer systems used in Quality Control and support computer systems validation projects. Time permitting, also support Compliance department responsibilities including but not limited to vendor qualification program, annual product reviews, internal audits, metrics collection across the company, and preparing for monthly quality council/management review meetings.

 

 

EDUCATION, SKILLS AND/OR EXPERIENCE

Responsibilities

Primary Responsibilities

  • Primary administrator for computer systems used in QC, such as Empower and stand alone instruments
  • Primary administrator for MasterControl company wide document/training/event management software
  • Support Manager Computer Systems Validation in generating/executing computer systems validation documents
  • Prepare change control documentation related to troubleshooting and preventive maintenance activities related to system administration responsibilities
  • Review existing computerized systems for compliance to company procedures, computer validation requirements, data integrity and 21 CFR Part 11 compliance as assigned
  • Write/Review/Update SOP’s related to computer systems in QC and MasterControl
  • Performs internal audits to ensure compliance against procedures and regulations

Support additional Compliance Department responsibilities as time allows:

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)

Supports other department as directed which may include:

  • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis
Qualifications
  • Bachelors degree in life science such as Chemistry, Microbiology or related scientific field
  • 2-4 years Quality experience in the pharmaceutical industry
  • Experience with Computer System Validation following GAMP desired
  • Some knowledge of cGMP and FDA regulations
  • Proficient in the use of Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages
  • Experience with TrackWise, MasterControl or similar Quality Event Management software preferred
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