Lead Recruitment Consultant - Life Sciences at Orion Group
Orion Group Life Sciences are currently recruiting a Quality Engineer on behalf of our Multinational Pharmaceutical Client based in Sligo on an initial 9-Month contract with view to perm.
Job Summary:
* To ensure that products manufactured at the site comply 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.
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 the manner in which duties should be performed.
* The incumbent is charged with responsibility for ensuring product compliance to specification and Quality System compliance.
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.
Seniority Level: Associate
Employment Type: Temporary
Job Function: Pharmaceutical Manufacturing
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