QA Compliance Specialist

HERO

Job Detail

Location Dublin
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Emma Griffin
email quality@hero.ie

QA Compliance Specialist

Apply Now

Job ID: JOB-12218
QA Compliance Specialist – 12 month Contract

Location: Dublin

This is one of those exciting QA Compliance Specialist job opportunities that just stands out from the crowd! If you’ve been considering a career move then this QA Compliance Specialist role is well worth your time exploring, it will be hard to top on salary package and career growth. Located in well sought after location of Dublin you will be working in a super culture along with a great leadership team who genuinely care about their people’s well-being and career progression.

Key Responsibilities:

  • Represent the site Quality Assurance department as SME in compliance
  • Manage/input into SAP/POMs refinement initiatives.
  • Liaise with Site BTS and Operations functions as necessary to support compliance initiatives
  • Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, Manufacturing and IT areas.
  • Track and provide relevant quality metrics to Quality Management as required
  • Perform quality risk assessment of all GMP documentation systems and support stakeholders in the mitigation of compliance risks.
  • Prioritize risks and work with all site departments to ensure documentation and system compliance
  • Be current with regulatory requirements (FDA, HPRA) and possess a working knowledge of the documentation lifecycle Management in accordance with 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9,Q10, GAMP5 and all applicable regulatory requirements
  • Ensure alignment between the local and global compliance and QRM initiatives
  • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill AbbVie’s requirements
  • Write or review and approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate
  • Initiate action reports or deviation reports for any applicable nonconformance
  • Seek process innovation and continuous process improvements
  • Recognize and report to immediate supervisor any issues or deviations from accepted standards
  • Provide status updates on own activities and productivity challenges according to defined procedures
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training
  • Carry out and assist in the ongoing training of new and existing personnel, as appropriate
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses

Qualifications:

  • A third level qualification in Science, Engineering or related discipline, preferably a bachelor’s degree
  • Relevant industry experience (5+ years) including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry
  • 3+ years of experience in a quality assurance role.
  • Experience in compliance requirements for validating IT systems in accordance with regulatory Data Integrity controls including 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9, Q10, GAMP5 and all applicable regulatory requirements
  • SAP or ERP system experience
  • Excellent communication and interpersonal skills, including technical writing
  • Strong analytical and problem-solving skills
  • Maintain credibility and integrity.
  • Goal focused
  • Demonstrate passion and energy

For further information on this role in Dublin please contact Emma Griffin on +353 860334325 or email quality@hero.ie 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.

Emma Griffin

JOB-12218

Apply Now

QA Compliance Specialist

Emma Griffin

Role Type Fixed Term Contract
Contact Emma Griffin
email quality@hero.ie
mobile +353 86 033 43 25
linkedIn profile click here

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