QA NPI Specialist – Biologics

Desired Skills: npi,compliance specialist,qa specialist

PE Global is currently recruiting for NPI Compliance Specialist – Biologics for a Client site in Sligo:

This will be a 12-month initial contract role – days role – onsite

Responsibilities
• To ensure new products transferred to 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.
• 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, 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.
• Coordination of 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.
• 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.

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 gained 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 time     

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

 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 EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net  or  00353 21 4297900