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Technical Support Administrator - Formulation Development

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 12/04/2018
  • Job reference: J384685A

Technical Support Administrator

(Formulation Development)

A Technical Support Administrator is required to join a leading pharmaceutical manufacturing company based in the South East. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for providing the necessary technical administration support to the formulation development team, ensuring targets are attained to, to meet required product development time lines. This is a perfect opportunity to join a select team that has already established itself as a front runner leading the way in the Pharmaceutical industry in Ireland.

Job Responsibilities

To provide technical administration support to the formulation development team, ensuring that Formulation Development and GMP production targets (submission and Launch) are met and includes:

  • Archiving of Data/Worksheets/Logbooks/Notebooks/DT Batch Cards, etc
  • Co-ordinate and complete shipment of formulation samples to contract labs and/or customers
  • To measure and track Formulation Group metrics (e.g. training)
  • To generate, review and maintain New Material Assessments for all formulation development materials
  • Compilation of VA's / VQ's for new vendor / material set-up
  • Completion of Master Data paperwork required for new materials, packaging, equipment set-up, as required
  • Monitoring and completion of Formulation Group CACI's, IR's and Change Controls, as required
  • Assist in the designing of formulation development, process development and optimisation trials using experimental design techniques
  • To perform product and process monitoring through statistical analysis on both non-GMP development batches and GMP submission batches in order to support specification setting for drug products
  • To generate GMP documentation e.g. SOP's, batch manufacturing records and protocols
  • Compilation of ANDA and NDA summaries for submission to regulatory authorities and also for IND filings
  • To work with the New Product Introduction (NPI) Project Lead to ensure the smooth transfer of new products from submission batches manufacture to process validation and commercial manufacture

Health, Safety and the Environment

  • Comply at all times with the Health, Safety and Environmental policy and associated procedures
  • Continuously promote a positive safety culture by challenging yourself and others to prioritise safety in everything you do

Quality Compliance

  • Ensure all work carried out, follows the required standards, conforming to company, cGMP, SOP's and regulatory guidelines
  • Take ownership for quality compliance in all activities you are responsible for

Education/Experience

  • Third level qualification or equivalent work experience in a senior technical administration role.
  • Administration training (desirable)
  • Previous pharmaceutical experience
  • Practical experience in Formulation Development advantageous
  • Statistical analysis experience advantageous

Skills/Competencies

  • Technical administration and troubleshooting skills
  • Good organisational skills and attention to detail
  • Knowledge of production operations
  • Excellent written, oral and interpersonal skills are essential
  • Self-motivation and leadership skills are required
  • Strong attention to detail is critical
  • Knowledge of Quality by Design and Statistics
  • Knowledge and proficiency of Microsoft products
  • Ability to work under pressure, coping with more than one conflicting task at once is essential

Interested?

If this position excites you and are interested in becoming a part of a leading company in the Pharmaceutical/Biotech industry, do not hesitate to get in contact!

For more information contact Jack on 01 6455262 or email jack.conway-kenny at experis.ie

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