Sr Quality Compliance Specialist

2 weeks ago

Limerick, Limerick, Ireland Regeneron Full time

Within this role you'll be responsible for maintaining the site's compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.

As a Sr / Quality Compliance Specialist, a typical day might include, but is not limited to, the following

  • Being responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Administrating and oversight of site quality systems including but not limited to;
    • Deviations
    • CAPA
    • Change Control
    • Audits
    • Customer Complaints
    • Quality Risk Management
  • Reviewing and approval of the following types of documents, relating to area functions:
    • failure investigations
    • change control documents
    • corrective/preventative action documents
    • standard operating procedures
  • Maintaining electronic systems used for Change Control and Deviation Management
  • Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
  • Monitoring and trending metrics associated with site quality systems
  • Participate in continuous improvement initiatives
  • Participating in regulatory and customer audits
  • Participating in quality risk assessments
  • Collaborating with functional departments to resolve issues and maintain compliance
  • Identifying gaps in systems and develop feasible plans for correction
  • Training of personnel on quality system processes
This Role Might Be For You If You
  • Have proven experience in conducting on-site investigations and analysis (GEMBA walks)
  • Have the ability to identify and address operational inefficiencies
  • Have a track record of implementing process improvements based on findings from direct workplace engagement
  • Can demonstrate respectful behaviour at all times
  • Have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint

To Be Considered For This Positon You Must Hold

Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in pharmaceutical or related industry

Senior Specialist: BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of relevant work experience in pharmaceutical or related industry

#IREADV #JOBSIEPR #REGNIEQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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