Specialist to join a ground-breaking gene therapy organisation on a
permanent basis located in Shannon.
Please note that to be considered for this role you must have the
right to work in this location.
* KEY RESPONSIBILITIES:
* * You will be accountable for ensuring that own work complies with
GMP, Data Integrity and Good Documentation Practice (GDP) and is
undertaken in accordance with applicable procedures.
* Answerable for ensuring that own training is undertaken in a timely
and GMP compliant manner before the task is undertaken.
* You will develop technical subject matter expertise in the technical
support team and wider manufacturing operations.
* Project lead and formal reporting of tech transfer and validation
for each new product to establish manufacturing readiness for PPQ,
launch and subsequent lifecycle management.
* Responsible for product lifecycle management activities including
process validation of processes in line with ICHQ**Apply on the
website**.
* Management of change controls; providing impact assessments as a
technical functional, coordinating input and support from development
if required. Lead/support and/or coordinate the action plans.
* You will lead and provide technical support using established
problem solving techniques for investigations into quality events,
customer complaints and IMC actions. Provide technical
recommendations, co-ordinate and execute CAPA&#**Apply on the
website**;s.
* Responsible for ensuring that any GMP documentation assigned to me
e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs &
audit/inspection actions is closed timely and in a RFT state.
* REQUIREMENTS:
* * Scientific Degree or equivalent, preferably with a higher
qualification in a discipline related to bio-pharmaceutical sciences.
* Extensive industrial experience in Pharma/Bio within a GMP regulated
environment.
* Demonstrated interpersonal skills with ability to work
cross-functionally both with internal and external partners.
* Experience of transferring pharmaceutical products from Development
into a GMP manufacturing environment and successfully gaining approval
and launching new products commercially.
* Excellent communication skills.
* Knowledge of the Regulatory compliance requirements within Europe
and the USA.
* Demonstrated experience in the management of root cause analysis
investigations utilising Lean/Six Sigma tools.
* Ability to manage, multiple, cross functional projects to deliver
against key project milestones and deadlines.
* Experience of managing workload of small teams to meet deadlines.
* Excellent verbal and written communication skills, in English.
* Ability to present effectively to groups.
* Excellent influencing skills and ability to establish effective
working relationships with personnel at all levels.
* Thorough working knowledge of ICH guidelines and current Good
Manufacturing Practices.
* Apply now*:
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 currently have an opportunity for a Tech Transfer
Specialist to join a ground-breaking gene therapy organisation on a
permanent basis located in Shannon.
Please note that to be considered for this role you must have the
right to work in this location.
* KEY RESPONSIBILITIES:
* * You will be accountable for ensuring that own work complies with
GMP, Data Integrity and Good Documentation Practice (GDP) and is
undertaken in accordance with applicable procedures.
* Answerable for ensuring that own training is undertaken in a timely
and GMP compliant manner before the task is undertaken.
* You will develop technical subject matter expertise in the technical
support team and wider manufacturing operations.
* Project lead and formal reporting of tech transfer and validation
for each new product to establish manufacturing readiness for PPQ,
launch and subsequent lifecycle management.
* Responsible for product lifecycle management activities including
process validation of processes in line with ICHQ**Apply on the
website**.
* Management of change controls; providing impact assessments as a
technical functional, coordinating input and support from development
if required. Lead/support and/or coordinate the action plans.
* You will lead and provide technical support using established
problem solving techniques for investigations into quality events,
customer complaints and IMC actions. Provide technical
recommendations, co-ordinate and execute CAPA&#**Apply on the
website**;s.
* Responsible for ensuring that any GMP documentation assigned to me
e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs &
audit/inspection actions is closed timely and in a RFT state.
* REQUIREMENTS:
* * Scientific Degree or equivalent, preferably with a higher
qualification in a discipline related to bio-pharmaceutical sciences.
* Extensive industrial experience in Pharma/Bio within a GMP regulated
environment.
* Demonstrated interpersonal skills with ability to work
cross-functionally both with internal and external partners.
* Experience of transferring pharmaceutical products from Development
into a GMP manufacturing environment and successfully gaining approval
and launching new products commercially.
* Excellent communication skills.
* Knowledge of the Regulatory compliance requirements within Europe
and the USA.
* Demonstrated experience in the management of root cause analysis
investigations utilising Lean/Six Sigma tools.
* Ability to manage, multiple, cross functional projects to deliver
against key project milestones and deadlines.
* Experience of managing workload of small teams to meet deadlines.
* Excellent verbal and written communication skills, in English.
* Ability to present effectively to groups.
* Excellent influencing skills and ability to establish effective
working relationships with personnel at all levels.
* Thorough working knowledge of ICH guidelines and current Good
Manufacturing Practices.
* Apply now*:
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.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
