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IT Compliance Analyst

Title : IT Compliance Analyst profile
Sector : IT / Software
Location : Limerick
Reference : CW121639
Contact : Diarmuid Buckley
Office : Cork
Tel : +353 (0)86 072 7776
Email : dbuckley@careerwise.ie

Job Description

An IT Compliance Analyst / Technical Writer is required by CareerWise Recruitment for our Mid West based Biotech Client. Please contact Diarmuid Buckley for full details.

Role of this position

  • Ensures IT procedures are in compliance with regulatory and corporate requirements
  • Ensures IT personnel are operating in compliance with regulations and procedures
  • Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management System
  • Evaluates, develops and modifies IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations
  • Provides IT with Technical Writing assistance
  • Tracks and reports on IT Quality metrics
  • Works closely with QA Validation to ensure IT systems are validated and maintained in a validated state
  • Represents IT or assists IT SME's during in internal and external audits
  • Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc
  • Assists IT personnel in writing/responding to Deviation/Events including detailed event investigation and root cause analysis
  • Tracks and facilitates the remediation activities associated with IT-related CAPAs

JOB REQUIREMENTS

  • BS/BA in related field OR relevant industry experience for educational requirement.
  • Strong preference for QA experience within an IT department
  • Ideally 3 years+ of pharmaceutical or biotechnology industry experience.
  • Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5
  • Knowledge and experience of Quality Management Systems
  • Knowledge and experience of SDLC methodologies in a cGMP regulated environment

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.



Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

 

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Careerwise Recruitment



IT Compliance Analyst

Title : IT Compliance Analyst profile
Sector : IT / Software
Location : Limerick
Reference : CW121639
Contact : Diarmuid Buckley
Office : Cork
Tel : +353 (0)86 072 7776
Email : dbuckley@careerwise.ie

Job Description

An IT Compliance Analyst / Technical Writer is required by CareerWise Recruitment for our Mid West based Biotech Client. Please contact Diarmuid Buckley for full details.

Role of this position

  • Ensures IT procedures are in compliance with regulatory and corporate requirements
  • Ensures IT personnel are operating in compliance with regulations and procedures
  • Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management System
  • Evaluates, develops and modifies IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations
  • Provides IT with Technical Writing assistance
  • Tracks and reports on IT Quality metrics
  • Works closely with QA Validation to ensure IT systems are validated and maintained in a validated state
  • Represents IT or assists IT SME's during in internal and external audits
  • Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc
  • Assists IT personnel in writing/responding to Deviation/Events including detailed event investigation and root cause analysis
  • Tracks and facilitates the remediation activities associated with IT-related CAPAs

JOB REQUIREMENTS

  • BS/BA in related field OR relevant industry experience for educational requirement.
  • Strong preference for QA experience within an IT department
  • Ideally 3 years+ of pharmaceutical or biotechnology industry experience.
  • Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5
  • Knowledge and experience of Quality Management Systems
  • Knowledge and experience of SDLC methodologies in a cGMP regulated environment

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.



Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

 

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