Lead Compliance Documentation Specialist

HERO

Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Dee Curley
email dee@hero.ie

Lead Compliance Documentation Specialist

Apply Now

Job ID: JOB-12681


Lead Compliance Documentation Specialist 

* Remote working opportunity*

Our client, a highly successful and growing technology company, are looking for an enthusiastic Lead Compliance Documentation Specialist to  drive the CSV/CSA  standards within the  organization.

Position Summary

Reporting to the Test Manager, the individual will be focused on delivering and ensuring the business, quality, and compliance standards are met and continuously reviewed for improvement.

This position requires excellent communication and influencing skills, written and verbal, with the ability to interact across all levels of the business

The successful candidate will have a strong interest in compliance and delivering process change in a software development environment. The candidate will be a strong team player, ability to problem solve, enjoy working in a dynamic and delivery focussed environment, and have a drive to implement change,

If this sounds like you, we want to hear from you!

 

Primary Responsibilities

 

  • Lead the CSV/CSA strategy for the Software Development process – help drive the transition from CSV to CSA standards
  • Ensure all audit requirements and deliverables are in place, current and adhered to (RFS, RTM, OQ, IQ) for software delivery
  • Ensure corrective action / preventative action measures are put in place to drive improvement
  • Actively participate in the internal and external audits regarding software development processes and protocols.  Represent the organization in more complex risk and impact assessments.
  • Review audit requirements for continuous improvement aligning with industry standards
  • Provide training and mentoring on standards for all development resources
  • Keep up to date with industry regulation standards
  • Develop, write, review and approve SOP’s and Control Documents to support software development activities
  • Review and approval on software release documentation – ensuring all standards are adhered to

 

Minimum qualifications

 

  • Degree or higher in a science, engineering, IT, or similar discipline.
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
    Ability to prioritize, manage multiple tasks, and meet deadlines
  • Excellent leadership skills with a collaborative approach
  • Understanding of ISO9001:2015 requirements and/or requirements for systems qualification in a regulated environment.
  • Proven knowledge and understanding of IT/Life Sciences industry regulations, including FDA and GxP requirements.
  • Experience of internal and external customer audits
  • Understanding of the Software Development Process
  • Work experience within regulated life sciences or IT industries a preference.

 

Desirable:

 

  • Work experience within a software development organization

 


Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/


Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Dee Curley

JOB-12681

Apply Now

Lead Compliance Documentation Specialist

Dee Curley

Role Type Permanent
Contact Dee Curley
email dee@hero.ie
mobile +353 86 790 21 91
linkedIn profile click here

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