Quality Engineer

Orion Group Life Sciences are currently recruiting a Quality Engineer on behalf of our Multinational Pharmaceutical client based in Sligo on an initial 12-month contract with strong potential to extend.
 
Days Role Initially. Possibility of Shift in future.
 
Job Summary:

• To ensure that products manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.
• To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice.

 
Key Responsibilities:
 

• Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
• Audit the quality system with other personnel where required.
• Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.
• Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
• Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc.
• Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
• Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
• Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.
• Ensure implementation and compliance with relevant Regulator requirements.
• Assist in the performance of validation activities at the site.
• Ensure Quality System documentation is thorough, complete, and compliant.
• Ensure compliance with training requirements is maintained.
• Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.
• Inspect incoming products and manage the supplier Quality relationship.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Where required. Review batch records, ensuring documentation is compliant with requirements.
• Complete disposition decision for the batch.
• Participate in Risk Management activities as required.

 
 
 
Essential Requirements
 

• Degree in an Engineering, Science, Quality or other discipline

 
Desired Requirements
 

• A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.

 
Experience Required
 
Technical/Business Knowledge
 

• 2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
• Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.
• Experience in an injection moulding or tooling environment is desirable.

 
 
Cognitive Skills
 

• The position requires a high level of attention to detail and mental concentration, to ensure total compliance with operating procedures and Regulations at all times.
• The position requires proven problem-solving skills, and the ability to adapt to new processes on a regular basis.
• The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times.
• The position requires total commitment to quality and safety at all times.
• The position requires the ability to continuously improve the Quality System and methods of work.

 
Ownership/Accountability
 

• This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
• Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
• The position has a high level of autonomy, and individuals are expected to work on their own initiative.
• Demonstrates an ethos of Right First Time at all times.
• Adheres to and follows all procedures, policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures and guidelines.
• Shows a high level of tenacity to ensure closure of issues.

 
Influence/Leadership
 

• May be required to support Cross functional teams and cost improvement projects.
• Complies with cGMP at all times.
• Considerable and continual care and attention to detail is needed to detect and avoid errors.
• Continual attention needed to ensure plant reaches its Quality objectives.
• Leads by example through compliant behaviour / actions.

 
Decision Making/Impact
 

• Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
• Expected to handle all day-to-day training, learning & development queries, if major problem can refer to Quality Manager.
• Responsible for the presentation of technical data to stakeholders to ensure prompt decisions on training/learning and development related issues.

 
Supervision Received
 

• The incumbent has set targets and goals to achieve which are reviewed on a weekly/monthly basis.
• The incumbent receives only general instructions from management personnel as to manner to which duties should be performed.
• The incumbent is charged with responsibility for ensuring product compliance to specification and Quality System compliance.

 
Supervision Provided
 

• No direct reports.

EHS Requirements

• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.