Collins McNicholas

Role Purpose:

  • To provide high quality analytical and technical support to internal and external (i.e. regulatory) customers, to ensure that analytical infrastructure is in place to support the introduction of new products and support regulatory activities.
  • To promote and monitor laboratory GMP / Safety within the Analytical Development (AD) group such that the AD laboratory is maintained as an inspection ready facility.
  • To actively participate in the development of the AD group as a centre of excellence.

 

Role Responsibilities:

Routine Analysis:

  • Liaise with Technical Development, Quality Control or Process team members to identify priorities, Communicate requirements to the AD group or Senior AD Chemist
  • Carry out routine analysis including sample validation peer review and approval of AD samples. Samples to include homogeneity samples, buying samples and process development samples.
  • Prepare and issue AD reports detailing the background, investigation and conclusion of quality issues, as required

Participation in Cross Functional Teams:

  • Participate as required in cross-functional teams (internal and external).
  • Communicate outputs/milestones to senior management or Senior AD Chemist, and where applicable co-ordinate the implementation of recommendations/agreements in the organisation.

Laboratory GMP Compliance:

  • Obtain a working knowledge of all relevant site and analytical Standard Operating Procedures (SOPs)
  • Maintain laboratory notebooks and proforma testing sheets in compliance with GMP requirements
  • Carry out calibration of equipment and analytical balances as required.

Analytical Method Development and Validation:

  • Carry out development/optimisation of new or established analytical methods
  • Perform validation of new analytical methods, periodic method validation reviews, issuing or upgrading validation reports in line with current Regulatory expectations

Technical Support or Troubleshooting for Existing Products:

  • Provide technical data/opinion to both internal and external customers where required
  • Participate in cross-functional meetings/teleconferences (internal and external) as appropriate, including regulatory meetings
  • Participate in Quality Investigation Process as required
  • Where applicable, communicate additional/revised testing requirements to Quality Control (QC) and the coordination/preparation of supporting documentation in the event of a subsequent filing.

New Product Technology Transfer:

  • Attend and participate in technology transfer cross-functional and analytical technology transfer meetings
  • Obtain details of method/equipment requirements (including reference standards) to allow bench evaluations to be carried out. In the case of new equipment requirements, ensure appropriate procurement, installation coordination, IQ/OQ signoff, training, etc .
  • Carry out paper and bench evaluations of all key analytical methods. Evaluations should be carried out with the knowledge of QC requirements, Apply Design for Manufacture (DfM) principles where appropriate.

Senior Analytical Development Chemist Designate:

  • Prepare and support the AD lab for internal and external audits
  • Approval of Laboratory Investigation Reports
  • Lead and behave in accordance with our cultural framework

 Environmental Health & Safety (EHS) Responsibilities:

  • Perform duties in a compliant manner and behave in accordance with site SOP’s, company EHS standards and guidelines and relevant legal requirements
  • Read and understand Standard Operation Procedures applicable to role
  • Be aware of the impact of your job activities on EHS issues

Quality Responsibilities:

  • Perform duties in a compliant manner and behave in accordance with Quality Management System requirements.
  • Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to.
  • Maintain GMP standards.
  • Be inspection ready at all times

 

Role Requirements:

  • Honours degree in chemistry/analytical chemistry
  • Preferably a PhD/Masters in analytical chemistry
  • Candidate must have expertise in analytical tech transfer
  • An up to date knowledge of Quality guidelines e.g. ICH, FDA, IMB, QMS and GMP
  • Have a sound technical knowledge of their specific discipline and good understanding of critical business functions on site.
  • Detailed knowledge of the cGMP requirements relevant to the role and understand the company Global Quality Policies and Global Quality Guidelines that relate to the role
  • Embrace Quality Leading Edge Principles and Behaviours
  • Familiar with GMP as applied to an analytical laboratory
  • A demonstrated commitment to Quality/QMS, EHS, OE/Continuous improvement and Leading Edge behaviours
  • At least 3 years relevant experience
  • Experience of interacting with R&D Chemical Development Analytical Sciences

For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email aisling.lane@collinsmcnicholas.ie

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