Our client is seeking a highly skilled QC Analytical Expert to join their team on a contract basis. This exciting opportunity will see you working closely with pharmaceutical and healthcare clients based in Waterford, delivering analytical expertise and driving project success.
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Key Responsibilities:
* Providing analytical support for projects, troubleshooting, and investigations on analytical methods and lab technologies
* Coordinating analytical testing on projects (validation/transfer), ensuring adherence to scheduled plans
* Performing tasks in accordance with cGMP and HSE requirements, with associated instructions, procedures, and records
* Recording raw data, calculations, and information related to tasks, complying with cGMP and Data Integrity requirements
* Writing and reviewing protocols and reports related to analytical validation/transfers and qualification activities
* Writing and reviewing accurate analytical methods procedures
* Informing managers of quality or HSE events (deviations or OOs) in a timely manner
* Participating actively in investigations, where involved, to ensure investigations and impact assessment are performed appropriately
* Performing trend analysis on method performance to determine the need to revalidate, optimize, or replace the method
* Ensuring lab facilities and instruments are kept in a quality and safety status
* Supporting QC teams during internal and external audits and inspections
Required Skills and Qualifications:
* Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements
* Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement
* Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements
* Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
Desirable Characteristics:
* Flexible approach, comfortable with ongoing change and improvement
* Ability to drive project deliverables to closure
* Ability to work autonomously while maintaining communication with key stakeholders
* Ability to articulate issues and communicate at all levels
* Willingness to take ownership for resolution of departmental and/or cross-functional issues
* Creative and innovative approach
* Ability to interact effectively in multi-disciplinary teams
* Strong team player
* Excellent communicator
* Excellent attention to detail
* Brings scientific rigour and discipline to approaches