|Role Type||Fixed Term Contract|
Senior Compliance Specialist – NPI
Job ID: JOB-11748
Senior Compliance Specialist – NPI
My client a leading pharmaceutical manufacturer is recruiting for a Senior Compliance Specialist to join their Sligo site on a 1 year fixed term contract.
As a new Snr. Compliance Specialist, you will ensure new products transferred to the Sligo 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.
- 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 and Technical Skills:
- 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 in Pharma or Medical Device industry.
- 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.
For further information on this Senior Compliance Specialist role in Sligo please contact Mark Wilson on +353860449473 or email@example.com
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