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NPI Compliance Specialist (Biologics)

ID
14515
Location
Sligo, Ireland
Role Type
Contract
Contact
Hannah Doyle
Email
engineering@hero.ie
Phone
+353 86 107 0950
LinkedIn
click here

NPI Compliance Specialist (Biologics)

Similar Jobs

NPI Compliance Specialist (Biologics)

Job Dept: Quality Assurance
Reports to: Quality Operations Manager

Responsibilities:

  • Ensure new products transferred to the site are manufactured following applicable regulatory requirements and policies.
  • Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.
  • Support 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, clients, 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.
  • Coordinate site review of new product-related material specification documents including but not limited to in-process, BDS, Drug Product, raw material, and excipient specifications.
  • Support review and approval of new product-related Analytical Test Method Transfers and/or validation.
  • Manage new product-related exception documentation, including the generation of corrective and preventative actions to prevent reoccurrence.
  • Generate product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
  • Interface with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
  • Adhere to and support all EHS & E standards, procedures, and policies.

Requirements:

  • 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.
  • Regulatory, quality, and new product introduction background.
  • Desirable: 2 years’ experience gained within an aseptic processing environment, ideally within a quality function.

Cognitive Skills:

  • 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.

Ownership/Accountability:

  • Has a personal responsibility to engage and align with the company's Strategic Imperatives, and to consistently execute in accordance with the company's Operational Pillars and Ways of Work.
  • The position has a high level of autonomy and individuals are expected to work on their own initiative.
  • Shows a high level of tenacity to ensure closure of issues and projects assigned.
  • Demonstrates an ethos of Right First Time at all times.
  • Ensures team compliance with procedures, policies, and guidelines, ensuring adherence to cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines at all times.

Influence/Leadership:

  • May be required to support cross-functional teams and cost improvement projects.
  • Provides guidance to suppliers as required to maintain a compliant, efficient relationship.
  • Provide technical leadership to functional areas and collaborate with key stakeholders.

Decision Making/Impact:

  • Decision making within the confines of quality systems in relation to applicable regulatory and international standards.
  • Expected to handle all day-to-day quality issues/queries from the operations function; however, if a major problem occurs, they will confer with relevant personnel or Team Leader.
  • Decision making within the confines of agreed responsibility with Team Leader.

Supervision Received:

  • Individual is given authority to carry out their duties without close supervision.
  • Reports to Quality Operations Manager.

Supervision Provided:

  • No direct supervisory responsibilities.
  • Close contact with personnel at all levels.

EHS Responsibilities:

  • Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
  • Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
  • Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in the EHS system.
  • Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement in the EHS system.
  • Attend all required EHS training and medical surveillance programs.
  • Wear PPE as required.
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