Technical Services Specialist
- NI & Ireland
- Contract
- Life Sciences
This vacancy has now expired
The contract duration is 12 months and 40 hours per week.
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug product manufacturing operations performed at contract manufacturing organisations (CMOs).
Key Responsibilities for the Technical Services Specialist:
- Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and late stage clinical products at CMOs.
- Lead troubleshooting efforts and high-level deviation investigations in conjunction with contractors and internal partners (Process Development, Manufacturing, and Quality).
- Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
- Technical review of change controls for impact to product quality, safety and efficacy.
- Provide on-floor technical support and troubleshooting at the CMO facility.
- Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
- Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
- Collection, organisation, trending, and analysis of GMP manufacturing data.
- Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
- Support establishment of validation plans and evaluation of drug product production site options
- Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
- Up to 25% international travel required.
Please apply now for more information:
Direct number: 01442 860 525.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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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
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
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