Technical Transfer Specialist (FTC 12 months)
Hobson Prior are seeking for a Technical Transfer Specialist (FTC 12 months) to join a fantastic biotech organisation on a fixed term contract basis located in London. Our client is focused on generating remedies that might be possible cures for those who suffer from serious illnesses.
Please note that to be considered for this role you must have the right to work in this location.
- Guide and/or offer technical assistance using practices for resolving issues on investigations into quality events, customer complaints and IMC actions.
- Offer technical suggestions, arrange and implement CAPAs, etc.
- For this role, you will be accountable for product lifecycle management actions which involves process validation of procedures aligned with ICHQ8-10.
- Accountable for guaranteeing that own training is assumed in a GMP compliant and timely manner before completing the task.
- Responsible for management of change controls; offering impact examinations as a technical functional, arranging contributions and aid from development if needed.
- You will guide/help and/or arrange the action plans.
- Manage the development of technical SME in the technical support team and broader manufacturing operations.
- Serve as a project leader/management and handle formal reporting of tech transfer and validation for product to form manufacturing promptness for PPQ, launch and subsequent lifecycle management.
- Accountable for guaranteeing that own work complies with GMP, data integrity, GDP and is assumed rendering to appropriate processes.
- The ideal candidate will be accountable for assuring that any GMP documentation allocated are closed in a RFT state and timely manner, documents such as Issues, CAPAs, Change Controls, BMRs & audit/inspection actions.
- Educated to a degree level in a biopharmaceutical science discipline or similar.
- Demonstrable experience working within a pharma/bio organisation in a GMP regulated setting.
- Interpersonal abilities with the capacity to work cross-functionally with both internal and external partners.
- Familiarity in transferring pharmaceutical products from development into s GMP manufacturing setting as well as successfully obtaining approval and launching new products commercially.
- Communication skills both verbally and in writing.
- Expertise on regulatory compliance needs in Europe and the US.
- Acquaintance with management of root cause analysis investigations utilising lean/six sigma tools.
- Past involvement handling workload of small teams to meet deadlines.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Hobson Prior are currently looking for a CMC Technical Writer - Microbial Vector to join a fantastic biopharmaceutical organisation on a contract basis.
Limerick, Republic of Ireland
Hobson Prior are collaborating with a brilliant biotech organisation who are currently seeking for an individual to join their team on a permanent basis.
Hobson Prior are currently looking for a QC Process Support Specialist to join a brilliant pharmaceutical organisation on a permanent basis.
£24000 - £29000 per annum
Hobson Prior are currently looking for a QC Micro Analyst to join a brilliant biotech organisation on a permanent basis located in London.