The Opportunity:

This is an opportunity to be part of a dynamic team within the quality function. We are looking for individuals to provide technical expertise to assist in the analytical testing on finished product & raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs and to provide support as required to the Head of Quality.

KEY RESPONSIBILITIES:

• Ensure that all testing is conducted in accordance with current EU and US regulatory requirements. Data integrity is of paramount importance and must comply with current guidelines.
• Ensure completion of testing to allow for timely release of raw materials for use in manufacture and finished product for release to the market.
• Maintenance of the QC stability testing program.
• Ensure timely review and approval of laboratory results, protocols and reports.
• Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate. Ensure all laboratory equipment is maintained and calibrated.
• Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory
• Ensure timely completion of method transfer activities in accordance with relevant procedures.
• Ensure method development and validation is conducted in accordance with the relevant regulatory procedures and in adherence with the agreed timeframe.
• Ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
• Scheduling of analysis, prioritising work across Chanelle Loughrea and in conjunction with Chanelle Jordan Laboratory.
• Ensure statistical trend analysis is completed in accordance with current GMP/GLP requirements.
• Review all laboratory notebooks, records, chromatograms etc. to an acceptable GLP standard and up to date at all times.
• Assist the Head of Quality in hosting Regulatory inspections and Customer audits.
• Ensure that corrective actions identified as a result of observations raised during regulatory & customer audits are implemented in a timely manner.
• Ensure that all GMP/GLP related documentation is regularly reviewed and updated in accordance with Company policy.
• Review and approve company standard operating procedures.
• Provide monthly measurements on Key Performance Indicators (KPI’s) to reflect the performance of the Laboratory function.
• Conduct performance reviews with Laboratory personnel in accordance with the Company performance management system.
• Identify training and on-going development opportunities for laboratory personnel and training records maintained.
• Ensure that continuous improvement initiatives are identified and implemented in the laboratory as appropriate.
• Assist in the selection and recruitment of Laboratory personnel in conjunction with Human Resources.
• Monitor the laboratory capacity to ensure that the resources meet the requirements of the business and take appropriate corrective measures as required.
• Ensure the laboratory operates within the requirements of the budget on a monthly basis.
• Any other duties assigned by the Head of Quality

COMPETENCIES:

• Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands.
• Ability to lead a team and manage diverse personalities and viewpoints.
• Ability to build relationships and collaborate with others.
• Excellent communication skills, both verbal & written.
• Ability to prioritise decision making differentiating between urgent and non-urgent.
• Maintains the highest standards of ethical behaviour. Escalates issues appropriately. • Practical, action-orientated approach to managing priorities. • Strong analytical ability and associated problem solving. • Flexible and shows willingness to learn to develop technical skills.
• Takes a methodical, systematic and structured approach to organising work • Positive and proactive person who is energised by having great responsibility • Practical, action-orientated approach to managing priorities and teams. The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required and may be subject to change.

QUALIFICATIONS:

• 3rd level qualification – Bachelor’s degree in a science-based discipline.
• Minimum of 5 years in a pharmaceutical’s environment.
• Strong computer skills in MS Office
• Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines