Senior Compliance Specialist (NPI)

Science & Pharmaceutical
Science & Pharmaceutical
Sligo
Fixed Term Contract
17332
Sligo
Fixed Term Contract
17332

Senior Compliance Specialist (NPI)

Are you interested in joining a company where you can unleash your full potential? This opportunity offers a great stepping-stone into an expanding Sligo site with global reach. Be part of a diverse and innovative team to play a key role in ensuring new products transferred to the site are manufactured following applicable regulatory requirements and policies.

 

This is a high-potent commercialization and launch facility for small molecule API and Oral Solid Dose products with a positive culture that promotes a healthy work life balance.

 

Key Responsibilities:

  • Responsible for maintaining the effectiveness of the integration of new products into the quality system.
  • Senior NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
  • Support vendor evaluation and approval, managing all technical agreements from initiation, review, approval, and storage.
  • Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
  • Collaborate with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns.
  • Coordination of site review of new product related material specification documents including but not limited to intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications.
  • Support review and approval of new product related analytical Test Method Transfers and/or validation.
  • Support the management of new product related exception documentation, including the generation of corrective and preventative action to prevent reoccurrence.
  • Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
  • Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
  • Adheres to and supports all EHS & E standards, procedures and policies.

 Education:

  • A third level qualification in a science, quality or relevant discipline.
  • A minimum of three years experience in a quality role supporting new product introductions.
  • Strong knowledge of regulatory requirements is required.
  • Strong interpersonal and decision-making mindset with experience leading projects
  • High level of attention to detail and mental concentration to ensure accuracy and total compliance with Quality procedures at all times.

 

Our client is an Equal Employment Opportunity Employer who values bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

This role is well remunerated and offers ample opportunity to develop and advance your career.

Initially the role will be offered out as a 1 year fixed term contract with longer term prospects.

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For a confidential discussion and more information on the role, please contact Davin Ferguson.

davin.ferguson@collinsmcnicholas.ie

071 9140251

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Your Consultant
Davin Ferguson
Principal Recruitment Consultant