GMP Licence Submissions specialist
A global pharmaceutical organization are currently looking for an experienced Compliance Specialist for an initial 11 month contract role based on Ireland’s east coast.
The Compliance Specialist will support audit preparation and inspection readiness activities as required, in collaboration with the Compliance & Internal Audit teams. The Successful candidate will ensure that objectives are effectively achieved, consistent with the requirements to ensure compliance, safety and reliable supply to our customers.
- Lead the preparation activities for the submission of the site Manufacturer’s Importation Authorisation (MIA)/Commercial GMP license application
- Lead the preparation of the Site Master File and associated site documentation required as part of MIA submission
- Support for related Compliance deliverables in support of audits and inspection readiness
- Support for Recall QMS topic
- Provide Quality and cGMP input and support for audit and inspection readiness activities
- Support the site Document / SOP management systems
- Support for various GMP and Quality Training programs & Knowledge Management activities
- Support for MIA variations, as applicable
- Other general specified tasks e.g. global quality metrics, internal audit metrics
- Provide compliance contribution to project teams and leads small projects
- Coaches and guides colleagues on compliance related topics and deliverables
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming company and regulatory expectations and compliance changes/challenges
QUALIFICATIONS AND EXPERIENCE
- Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)
- Minimum 5 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role
- Experience in startup facilities a distinct advantage
- Experience of MIA submissions, Site Master File compilation and electronic quality management system tools is required
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements
- Demonstrated problem solving capabilities
- Ability to operate efficiently in a complex matrix organization and global environment
- Ability to self-motivate and work independently and as a team
- Strong leadership and interpersonal influencing skills
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
- English fluency written and spoken (the Company language)
Please apply NOW for more information.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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