QC Stability Supervisor

Dublin  ‐ Onsite
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Keywords

Description

A Global pharmaceutical company, is seeking a QC Stability Supervisor to Join there team on their busy manufacturing floor.

Main Objectives:
  • To manage the Stability Group to ensure the site stability program supports the release to market of safe and high quality products for the duration of their shelf-life.
  • To develop the Stability Group into an efficient and high performing unit.

Main Duties:
  • To supervise and develop the entire Stability team (both laboratory testing and stability coordination teams)
  • To participate in internal audits, corporate audits and Health Authority Inspections as the Stability subject matter expert in explaining and defending the stability program on site
  • To identify opportunities for optimization of the stability program on site.
  • To coordinate the stability program on site to ensure there are no gaps in the stability program, ensuring that all products where required are placed on Stability and tested as per ICH and cGMPs.
  • To ensure all documentation (stability protocols, reports, test methods, etc) is prepared and approved as per site/Global SOPs and as per cGMPs, EU and FDA guidelines
  • To report any out of specification results to the QA function in a timely manner. To investigate these to find an assignable root cause and implement timely CAPAs. To manage the stability testing program to provide optimum use of resources and efficient analysis ensuring all test and reporting schedules are met.
  • To manage relationships with external testing sites.
  • To ensure CAPAs arising from LIRs , investigations, change controls, internal audits & Health Authority Inspections are implemented as per agreed timelines
  • To ensure change control commitments are adhered to.
  • To develop and manage appropriate training systems for all personnel, to provide skilled and fully cross-trained staff within the team.

Requirements:
  • Minimum 3 years experience of coordinating an overall Pharmaceutical Stability Program.
  • Previous experience in team supervision.
  • A good working knowledge of Pharmaceutical Pack types, manufacturing processes and analytical processes for Oral solid dosage forms.
  • An in depth knowledge of ICH, EU and FDA guidelines on Stability and Analytical testing.
  • Third level qualification in a science related discipline.
  • Excellent communication skills and the ability to interact effectively with all stakeholders.


If you are interested in this great opportunity please contact me Anna Mooney o9r apply below with an up to date CV.
Start date
04/2014
From
Real Staffing
Published at
08.04.2014
Project ID:
691332
Contract type
Permanent
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