Tech Transfer and Validation Specialist

Employer
Hobson Prior
Location
Republic of Ireland, Shannon, Clare
Salary
£45180.50 - £54216.60 per annum
Closing date
22 Sep 2020

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
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Hobson Prior currently have an opportunity for a Tech Transfer and Validation Specialist to join an innovative gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. You will establish and develop the processes to Tech Transfer New Products and Analytical methods from Development into Manufacturing.

Job Responsibilities:

  • Accountable to develop Technical subject matter expertise and wider manufacturing operations.
  • Project Leadership formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, Launch and subsequent lifecycle management.
  • Accountable for Product Lifecycle Management activities including Process Validation of processes in line with ICHQ8-10.
  • Lead and/or 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's.
  • 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.

Key Skills:

  • Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
  • Excellent communication skills.
  • Strong 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.

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.
  • Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment and successfully gaining approval and launching new products commercially
  • Knowledge of the Regulatory compliance requirements within Europe, Japan and the USA.
  • Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma tools.
  • Previous experience of managing workload of small teams to meet deadlines.
  • In-depth 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.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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