Quality Compliance Specialist-Validation

4 weeks ago

Limerick, Limerick, Ireland Regeneron Full time
Quality Compliance Specialist-Validation

Join to apply for the Quality Compliance Specialist-Validation role at Regeneron

Quality Compliance Specialist-Validation

20 hours ago Be among the first 25 applicants

Join to apply for the Quality Compliance Specialist-Validation role at Regeneron

In this role you will be responsible for providing Quality Compliance oversight to the Validation department, ensuring processes are accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

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

  • Maintaining the Validation dept compliance tracker for quality records and engage with the team on a frequent basis on the status of their records (e.g. NOE-Notice of Event, CC – Change Controls, CAPA – Corrective Action Preventative Action)
  • Supporting reporting and driving closure of Quality Records
  • Mentoring quality record owners and complete compliance review where applicable to ensure quality records are submitted RFT (Right First Time)
  • Coordinating the reconciliation and return of documents (e.g. protocols, forms, logbooks) to the document control department in a timely manner
  • Supporting the Audit Ready 365 programme and work with the teams to plan, coordinate and track mentor sessions
  • Supporting internal and regulatory audits coordinating requests for the QA Validation team
  • Driving Quality and Compliance in our Validation activities by aligning practices as they relate to Compliance, Audit Readiness and Training for IOPS QA Validation
  • Collaborating to identify improvements across both sites
  • Developing and deploying Validation specific training
  • Influencing the development and revision of local and global policies, procedures and business processes in alignment with industry standards and best practices for Validation
  • Ensuring that all quality-based deliverables are complying with regulatory and quality policies and procedures and timelines are met and observations are corrected

This Role Might Be For You If You
  • Have the ability to maintain integrity and honesty at all times
  • Have the ability to work independently or as part of a team
  • Have the to communicate with transparency
  • Can continuously drive to improve processes for improved performance
  • Can demonstrate respectful behavior at all times
  • Have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint
  • Meets commitments on time
  • Can follow directions; performs well-defined tasks
  • Have effective time management skills

To be considered for this positon you must hold BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years experience. Experience within validation or quality compliance beneficial

#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.

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesBiotechnology

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