Senior Validation Specialist - Cold Chain
- Employer
- NonStop Consulting
- Location
- Limerick
- Salary
- £60000 - £80000 per annum
- Closing date
- Apr 18, 2019
View more
- Sector
- Science, Life Sciences, Cell and Molecular Biology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
My client is known for managing the entire drug life cycle without the use of CMO's or CRO's and as such you will get exposure to the entire process yourself.
This serves to both keep you challenged and also make your CV look a lot more attractive in the future for more senior positions, so a great opportunity to give your career a boost.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
* Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
* May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
* Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
* Reviews, edits and approves change control and SOPs.
* Collaborates with functional departments to resolve issues.
* May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department.
* May train/advise less experienced Specialists and Technicians.
* May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
* Assesses quality system documentation for completeness and accuracy, and dispositions documentation within the company's SOPs.
* Manages projects and prepares status reports.
* Interacts with Automation/Process Engineering for managing changes during qualification window.
* Strong communication/presentation skills during internal/external audits.
Experience and Required Skills: Education and Experience:
* BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; will substitute relevant experience for education
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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