Temp - Quality Compliance Specialist

Posted 20 days 9 hours ago by Initial Therapeutics, Inc.

Permanent
Full Time
Other
Not Specified, Ireland
Job Description
Responsibilities

In this role you will be responsible for maintaining site compliance of operations inclusive of Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation adhering to mandated regulatory requirements and site expectations.

Typical Day

A typical day might include, but is not limited to, the following:

  • Ensuring compliance with all aspects of Quality for the Raheen site and administration of site quality systems including Deviations, CAPA Change Control, Audits, Customer Complaints, Quality Risk Management
  • Reviewing failure investigations, change control documents, corrective/preventative action documents, standard operating procedures
  • Maintaining electronic systems, 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
  • Participating in regulatory and customer audits and quality risk assessments
  • Collaborating with functional departments to resolve issues and maintain compliance
Qualifications
  • You have a quality mindset and excellent attention to detail
  • You demonstrate strong interpersonal skills
  • You are comfortable working in a fast-paced setting

To be considered for this opportunity you should have a BS/BA in a scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry. Relevant experience may be substituted for education requirement.

For additional information about Regeneron benefits in the US, please visit For other countries specific benefits, please speak to your recruiter.

Equal Employment Opportunity

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.