Analytical Development Chemist

  • Reference: CJ46513
  • Job Type: Contract
  • Location: Cork, Cork City, Munster
  • Category: Science, Pharmaceutical & Food

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/approval of AD samples.
  • Prepare and issue AD reports detailing the background, investigation and conclusion of quality issues, as required

Laboratory GMP Compliance

  • Obtain a working knowledge of all relevant site and analytical Standard Operating Procedures
  • Maintain laboratory notebooks and proforma testing sheets
  • Carry out calibration of equipment and analytical balances as required. 
  • Ensure that the validation/calibration documentation associated with instrumentation is appropriately signed off before use

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
  • Participate in the validation of analytical methods, as requested. Typically, method equivalency, as per an agreed protocol or Measurement Systems Analysis (MSA) 

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

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.
  • Create, update analytical methods and specifications as appropriate.
  • Obtain analytical handover package, perform gap analysis and obtain missing documents/ data from sponsoring site
  • Provide bench and technical support to the validation campaign.
  • Prepare analytical documentation for regulatory filing

Senior Analytical Development Chemist Designate

  • Ensure that the AD group metrics are achieved through performance management
  • Manage and prioritise the activities of the AD group
  • Prepare and support the AD lab for internal and external audits
  • Promote good laboratory GMP within the laboratory.
  • Approval of AD and Buying sample reports

Decision Making and Problem-Solving Ability

  • Ability to make key decisions based on scientific data
  • Ability to use OE tools such as RCAs to solve problems in lab investigations, quality investigations


Environmental Health & Safety (EHS) Responsibilities

  • Perform duties in a compliant manner and behave in accordance with site SOP’s
  • Read and understand Standard Operation Procedures. Report all accidents, incidents and any EHS issues using the appropriate process/system
  • Ensure all engineering changes made have safety considerations
  • Ensure Basis of Safety files are available and up to date for processes

Quality Responsibilities

  • Behave in accordance with our Quality Management System requirements.
  • Maintain GMP standards.
  • Attend training and complete assessments as required.
  • Work in a GMP quality compliant manner at all times.

Role Requirements:

  • Honours degree in chemistry/analytical chemistry
  • PhD/Masters in analytical chemistry
  • 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
  • Detailed knowledge of the cGMP requirements relevant to the role
  • Embrace Quality Leading Edge Principles and Behaviours
  • Knowledge of the CAPA’s, project planning/management, managing groups, running QIPs.
  • Familiar with GMP as applied to an analytical laboratory
  • A demonstrated commitment to Quality/QMS, EHS, OE/Continuous improvement and Leading Edge behaviours

Basic Experience 

  • 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 Laura Jevens on 021 4911060 or email laura.jevens@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Laura Jevens

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  • Recruitment Consultant
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