QC Analytical Expert

QC Analytical Expert required for pharmaceutical and healthcare client based in Waterford. Contract role.

Responsibilities:

• Providing his/her analytical experts for any project, troubleshooting, investigation on analytical methods and lab technologies.
• Coordinate analytical testing on projects (validation/transfer), ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements
• Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities
• Writing/reviewing and maintaining accurate analytical methods procedures
• Informing his/her manager of any quality or HSE event (deviations or OOx) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Performing periodically trend analysis on method performance in order to determine the need to revalidate, optimize or replace the method
• Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately
• Supporting QC teams during internal, external audits and inspections

Skills and Experience

• Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
• Ability to analyse 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.

Qualifications

• Higher Level degree in science or equivalent technical discipline
• 3years + experience within Pharmaceutical Development, Analytical and/or Manufacturing department

Personal Characteristics

• Flexible approach, comfortable with ongoing change and improvement in the organisation
• Ability to drive project deliverables/goals to closure
• Ability to work autonomously while maintaining
• communication with key stakeholders.
• Ability to articulate issues and communicate at all levels, in
• particular with departmental management and program leads
• 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
• Seeing tasks through to successful completion.
• Excellent communicator.
• Excellent attention to detail
• Brings scientific rigour and discipline to approaches

Please call James Farrar today for further information on 0872489961 or email: jfarrar@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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