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Helsinn Birex Pharmaceuticals Ltd.

Validation Executive

Helsinn Birex Pharmaceuticals Ltd.

  • Dublin
  • Not disclosed
  • Fixed term contract
  • Updated 06/03/2013
  • Andrew Hayes
this job is expired
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Description

Helsinn require a QA Validation Executive for its manufacturing and OSD development site in D15. Email Andrew.Hayes@helsinn.com for info

 

Validation Specialist (12 Month C.o.E)

The Company

The Helsinn Group has a commercial presence in over 75 countries and has proven expertise in areas such as Oncology Supportive Care, Gastrointestinal and Pain & Inflammation medicines.

This job is based at the Group's finished pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals Ltd (FDA and IMB accredited) which has operated at Damastown Industrial Estate, Mulhuddart, since 1997. HBP develops, manufactures and packages finished dose forms in tabletting, granulate, capsule and gel formats along with the packaging of parenteral products. HBP also manages CMOs in for example the manufacture of sterile products. Please visit www.helsinn.com for an in-depth overview of the Group's activities.

JOB PURPOSE

The primary purpose of the Validation Executive is to lead validation projects to ensure the validated status of the manufacturing processes; equipment and facility are maintained at Helsinn Birex Pharmaceuticals. This role will involve generation, execution and close out of validation projects relating to existing products and new product introductions

JOB OUTLINE:

The following is a non-exhaustive list expressing the main duties and tasks associated with the role of Validation Executive. 

  • Supervising a small team of Validation personnel.
  • Supervision/Execution of all IQ, OQ, PQ Validation work.
  • Supervision/Execution of all process equipment (manufacturing, filling and packaging) and utilities qualifications.
  • Supervision/Execution of all software validation, cleaning validation and temperature mapping projects.
  • Co-ordination of Re-Validation of existing manufacturing and cleaning processes, equipment, utilities and software.
  • Writing and reviewing of protocols, reports and SOP’s required for the above.
  • Co-ordination of the scheduling and execution of the validation protocols, in co-operation with external vendors/ consultants where required. 

THE PERSON

The successful candidate will have graduated with a minimum of a BSc (life science) or BEng in a relevant discipline and will possess the following Knowledge, Skills and Experiences. 

  • At least 5 years experience working within a cGMP pharmaceutical manufacturing environment in in a Validation capacity.
  • Previous experience within a FDA approved facility.
  • In-depth (SME) experience of Equipment Validation
  • Previous experience of primary and secondary packaging equipment (EG Blister Packing and Cartoning) is essential.
  • Excellent Project Management, Communication and Relationship Management skills are essential with the ability to supervise a small team of validation personnel.
  •  
  • It would be desirable for candidates to have;
    • Experience of Process & Cleaning Validation
    • Supervisory Experience of small teams

Helsinn is an Equal Opportunity Employer and Welcomes applicants who meet the above criteria. Applications must be submitted by 10 March 2013. No recruitment agency assistance is required for this vacancy.

Ref: HBP ValExec
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Helsinn Birex Pharmaceuticals Ltd.

Helsinn Birex Pharmaceuticals Ltd.

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