NPI Compliance Specialist
- West
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a NPI Compliance Specialist to join their state of the art pharmaceutical facility.
Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports.
Responsibilities
- To ensure new products ae manufactured following applicable regulatory requirements and policies.
- Responsible for maintaining the effectiveness of the integration of new products into the NPI quality system.
- 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.
- Experience gained within an aseptic processing environment, ideally gained within a quality function.
- 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.
#LI-JS4
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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