Detail

Salary
negotiable
Location
Cork, Ireland
Posted by: Leo Pharma
17 Mar
44 Views
16 May expires

Senior Validation Specialist

Cork, Ireland
Job Description

At LEO Cork, we strive to create work environments that foster people management, development, engagement and collaboration, enabling us to build on LEO Pharma’s unique culture. Our people exhibit excellent teamwork and with a family like approach, are united in finding solutions. We provide our employees with the opportunity to increase the depth of their day to day responsibilities to enable flexible, cross functional, successful teams. At LEO Cork, we reward and recognise our people in a value adding way.

The Role

LEO Pharma Cork are currently recruiting a Senior Validation Specialist to join our team. This is a permanent position reporting to the Engineering Manager.

This position provides SME support and management of C&Q and validation activities at LEO Pharma Cork in order to assist internal stakeholders to meet current cGMP regulatory requirements (EudraLex Rules Governing Medicinal Products in the European Community Volume 4 and Annex 1-18, ICH Q7A) and Company procedures as per HPRA expectations.

 

Responsibilities  

  • Maintain and Improve the commissioning, qualification and validation systems within the company
  • Assist with risk assessments/change controls and deviations by providing input as a subject matter expert on behalf of validation
  • To assist and advise the validation of new/existing facilities, utilities, equipment and processes and liaise with production, QC and maintenance on qualification & validation scheduling
  • To review and evaluate URS/FS/SDS/HDS/FAT/SAT documents and reports to ensure a good design basis is established for all validation studies
  • Generate, review or execution of VMP/DQ/FQ/IQ/OQ/PQ/ protocols/reports for equipment, facility, utility, process & computerised systems.
  • Create/maintain site validation master plan or validation project plans as necessary
  • Manage external contractors in accomplishing validation project tasks where required
  • Create/maintain validation/engineering department related SOPs and WI documents
  • Implement and complete engineering/validation related CAPA and deviation actions
  • Use site Quality Management System software,
  • Maintain knowledge of current validation cGMP practices as per HPRA and EMA. 
  • Implementation of the Cleaning Validation program within the company
  • Implementation and co-ordination of the annual re-qualification studies i.e. temperature mapping or air quality testing executed by external contractors.
Job ID Reference
1483
Desired Skills & Experience
  • Minimum qualification of a bachelor’s degree in a scientific/technical discipline required
  • 5 – 8 years’ experience working with validation and qualification projects within GMP regulated environments.
  • Experience in contributing to GMP management systems such as change control/deviations/risk assessments.
  • Understanding of various validation concepts i.e. thermal/sterilization/facility/cleaning/equipment etc.
  • Strong understanding of API manufacturing.
  • Experience working across a Global business a distinct advantage.
  • Skilled in the execution of Risk Assessment and in the use of a variety of problem-solving techniques
  • Experience in projects, audits & inspections as Validation SME.
  • LEAN and Six Sigma philosophy are embedded in your day to day working.
  • Enjoy working closely with your stakeholders and have a hands-on operational approach to Validation.
  • A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude.
  • Work independently with strong personal drive.
  • Strong attention to detail and organisational skills with a quality focused mindset.
  • Have the ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner.
  • Strong business mindset.
Company
  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
  Workplace
 Cork, Ireland