Technical Services Specialist

Job Description

We have a current opportunity for a Technical Services Specialist on a contract basis. The position will be based in DUBLIN. For further information about this position please apply.

You will be responsible for:

* Provide significant technical expertise to support all aspects of the drug product manufacturing at the client Fill Finish Facility
* Process SME to support commissioning, automation and manufacturing operation teams.
* Support technology transfers of new products into the client Facility
* Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
* SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
* To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
* To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
* To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
* Technical review of change controls for impact to product quality, safety and efficacy.
* Provide on-floor technical support and troubleshooting.
* Partner with Operations to support protocol completion, execution and sample reconciliation.
* To generate documentation reports for technical studies
* Lead any key process changes using change control management system as required.
* Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
* Ensure compliance with site EHS policy, cGMP and other business regulations.

Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.

To find out more about Real, please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales