QA Specialist

at  AbbVie

Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
We are recruiting a Quality Specialist to join our diverse team in Clonshaugh, Dublin. Quality Assurance Validation team based in Clonshaugh. Their primary focus will be to enhance and maintain the quality oversight and compliance systems of validation activities on the Clonshaugh site. This position will primarily be involved in supporting and coordinating day to day activities in the areas of cleaning, facilities and equipment validation and will participates in knowledge transfer activities to become a QA Subject Matter Expert on new and developing processes. The position will also support the maintenance of the site equipment calibration programme and ensure that equipment performance is continually demonstrated
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Primary duties and responsibilities of the position are as follows. Other duties may be assigned.

• Represent the site Quality Assurance Department as SME in compliance,
• Manage / Input into SAP / POMs refinement initiatives,
• Liaise with Site Operations and BTS functions as necessary to support compliance initiatives,
• Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, 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,
• Support the Site Risk management efforts,
• Heavily involved in the coordination, building and approval of the site PQR requirements,
• Write, Review or Approve site CAPAs, LIRs and Complaints,
• Compile and Deliver quarterly Quality Management review for AbbVie North Dublin,
• Conduct Internal and External Audits and support preparation,
• Roll out Data Integrity Quality Plan for the site.
• Management of the Change review board and associated activities around metric reporting for changes across the site,
• Complete Supplier onboarding and approval, and material release from said suppliers in conjunction with appropriate above site global functions,
• Generation and progression of documents managed through the document management system and generation of metrics to be reported as part of management review. Prioritize risks and workload to ensure the dept and wider functions metrics are met from a documentation and system compliance perspective,
• Be current with regulatory requirements,
• Ensure alignment between the local and global procedural requirements and QRM initiatives,
• Write, Review and Approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate,
• Seek and deliver on process innovation and continuous process improvements,
• Recognize and report to immediate line manager any issues or deviations from accepted standards and metrics,
• Proactive escalation for potential events that may impact compliance or metrics to line manager,
• Proactive management of action items in advance of their due date to prevent delays and approval on time in accordance with site and system metrics,
• 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 by participating in Safety and Compliance Walks and actively highlight any safety / Compliance concerns to help drive the reduction of accidents / near misses or Compliance gaps.

QUALIFICATIONS

• A third level qualification in Science, Engineering or related discipline, preferably a Bachelor’s degree.
• Relevant industry experience (5+ years preferred) 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 including Eudralex, 21 CFR Parts 210, 211, ICH Q9, Q10 and other 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,
• Basic Microsoft Office Suite skills.
  Additional Information
  AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status

• Represent the site Quality Assurance Department as SME in compliance,
• Manage / Input into SAP / POMs refinement initiatives,
• Liaise with Site Operations and BTS functions as necessary to support compliance initiatives,
• Co-ordinate compliance activities for all systems for Manufacturing, Laboratory, 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,
• Support the Site Risk management efforts,
• Heavily involved in the coordination, building and approval of the site PQR requirements,
• Write, Review or Approve site CAPAs, LIRs and Complaints,
• Compile and Deliver quarterly Quality Management review for AbbVie North Dublin,
• Conduct Internal and External Audits and support preparation,
• Roll out Data Integrity Quality Plan for the site.
• Management of the Change review board and associated activities around metric reporting for changes across the site,
• Complete Supplier onboarding and approval, and material release from said suppliers in conjunction with appropriate above site global functions,
• Generation and progression of documents managed through the document management system and generation of metrics to be reported as part of management review. Prioritize risks and workload to ensure the dept and wider functions metrics are met from a documentation and system compliance perspective,
• Be current with regulatory requirements,
• Ensure alignment between the local and global procedural requirements and QRM initiatives,
• Write, Review and Approve protocols, reports and SOP’s to effect compliance gap remediation as appropriate,
• Seek and deliver on process innovation and continuous process improvements,
• Recognize and report to immediate line manager any issues or deviations from accepted standards and metrics,
• Proactive escalation for potential events that may impact compliance or metrics to line manager,
• Proactive management of action items in advance of their due date to prevent delays and approval on time in accordance with site and system metrics,
• 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 by participating in Safety and Compliance Walks and actively highlight any safety / Compliance concerns to help drive the reduction of accidents / near misses or Compliance gaps