Collins McNicholas

Role Responsibilities:

  • Troubleshoot, develop, transfer and validate robust, sound analytical methods.
  • To draft/ review test methods, validation protocols and reports as applicable.
  • Prepare submission documentation in support of license applications.
  • To take part in/lead laboratory investigations.
  • To liase directly with customers and contract laboratories and attend conference calls as required.
  • Attend internal project review meetings as required.
  • To assist in the preparation for customer/ regulatory inspections.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To analyse all raw materials, in process samples and finished products in a timely and efficient manner to ensure quality and efficacy of the product.
  • To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To support all other on-going laboratory functions & requirements.

 

Health and Safety

  • To ensure the requirements of company Safety Statement are implemented.
  • To continuously promote a positive safety culture by leading by example.
  • To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  • To report any defects/hazards

 

Role Requirements:

  • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
  • At least two years’ experience working in a related technical environment.
  • Strong analytical ability.
  • Strong quality orientation.
  • Good time management.
  • Strong attention to detail.
  • Good problem-solving abilities.
  • Excellent organisational skills.
  • Ability to multitask and work under pressure, coping with more than one conflicting task at once.
  • Excellent communication skills, both verbal & written.
  • Adaptability – ability to maintain effectiveness in varying environments and with different tasks, responsibilities and people
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
  • Ability to work effectively with a team to accomplish organisational goals
  • Knowledge of Project management skills
  • Proficient in the use of HPLC & associated problem solving.
  • Working knowledge of Empower laboratory software.
  • Proficient in dissolution testing
  • Proficient in the use of electronic document management systems.
  • Proficient in Technical report writing
  • Strong Safety awareness.
  • Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.

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

 

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