GMP Licence Submissions specialist
- Dublin
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
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.
POSITION RESPONSIBILITIES
- 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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I have always received a highly professional & personable service from the team at Quanta. 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
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 Quanta for seven years now and have always received a professional service. Quanta’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 Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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