Technical Team Lead – R&D Veterinary & Medical

Loughrea, Co. Galway

About Chanelle Pharma:

This is an opportunity to lead a dynamic function within the R & D team. We are looking for an individual
who will drive the R&D analytical teams in both the Medical and Veterinary functions and fulfil Chanelle
Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical
products and to provide excellent services and support to our customers.


In this role you will report into the Director of R&D in the Medical and Veterinary teams.

KEY RESPONSIBILITIES:

  • Provide technical support to the Medical and Veterinary R&D analytical teams to cover the
    disciplines including:
  • Day to day planning of the analytical activities and HPLC allotments
  • Successful Development of stability indicating methods (Active Assay, Related Substances
    and/or Preservatives, cleaning method) of the Pipeline products.
  • For analytical method validations
  • For resolving the analytical queries
  • Review and approve analytical documents e.g. ECP/STMs/AMT/AMV/PV protocols and any
    other reports
  • R&D Support to Registration for responding to technical queries on dossier submissions for
    new products and licence maintenance.
  • Responsible for addressing day to day lab issues related to maintenance of
    machines/calibrations/general maintenance/ implementation of new systems etc.
  • Review and approval of analytical data generated in the R & D Lab. Ensure the data is
    correct and no deviations made.
  • Ensure the log books/experiment registers are completed regularly.
  • Testing of the Laboratory trial samples as per the samples received from the Formulators
    and provide the results as per the agreed timelines
  • Characterization of APIs and Reference Products for the proposed Medical and Veterinary
    Products
  • Preparation of the Analytical Method Validation protocols and reports
  • Execution of method validation as per the method validation protocol
  • Process validation Testing of the Proposed Medical and Veterinary Products
  • Stability testing of Medical and Veterinary products charged on stability (Lab trials/pilot
    batches)
  • Stability Reports Preparation
  • Ensure availability of the required standards/columns and reagents to avoid delays in
    testing.
  • Update the stability Testing reports periodically
  • Perform trending on all the stability data
  • Review and approve the COAs
  • Review and approve specific reports prepared for the regulatory submission by crossreferring to the raw data.
  • Maintain the log of Dissolution and HPLC and any other instruments’ calibration and ensure
    that the calibrations are performed as per the schedule. If required address the technical
    issues.
  • Maintain the R & D lab as per GMP requirements
  • Report to Manager with any issues and close out points
  • Any other activity as per the Director of R&D’s instructions
 

COMPETENCIES:

  • Sound knowledge of analytical method development and validation in line with the ICH and GMP
    requirements
  • Hands on experience using HPLC/GC and empower software
  • Sound knowledge on the cGLP and cGMP requirements
  • Organizational skills, personal efficiency, time management skills and the ability to prioritize
    competing demands are key communication skills.
  • Ability to build relationships and collaborate with others is vital.
  • Demonstrate and lead on the values, initiatives and culture of an organization. Professional
    expertise.
  • Positive and proactive person who is energized by having great responsibility
  • Practical, action-orientated approach to managing priorities.
  • The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills
    required.
  • Strong computer skills in MS Office

QUALIFICATIONS:

  • Degree in Science Discipline or equivalent.
  • At least 10 years’ experience within the pharmaceutical industry in the analytical function
  • Sound knowledge of empower/GMP/GLP
  • Strong time management and organizational skills.

PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)

  • Manual Handling

WORK ENVIRONMENT:

  • Office & Laboratory Duties

Technical Team Lead – R&D Veterinary & Medical

Reference No: J0631
Loughrea, Co. Galway