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Senior Compliance Specialist NPI
- Full Time
- Mid-Senior Level
If you want to join a dynamic and vibrant team, we have an exciting opening for a Senior Compliance Specialist for an initial 12-month fixed term contract at our client’s manufacturing facility in Co. Sligo. In this role you will ensure new products transferred to site are manufactured following applicable regulatory requirements and policies.
Why you should apply:
- Joining a diverse and driven team, you will have the opportunity to work with advanced technology and industry-leading professionals.
- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
- Responsible for maintaining the effectiveness of the integration of new products into the NPI 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.
What you need to apply:
- 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.