Job Type: Full Time Permanent Salary: DOE Location: Dublin
Job Summary: Responsibility for compliance with the quality and regulatory requirements for combination medicinal and device products. This role is also responsible for overseeing the compiling and submitting of technical and quality documents to the relevant authorities in support of obtaining and maintaining the required medicinal product manufacturing authorizations. Reports directly to the Quality Assurance Manager.
Duties and Responsibilities:
Reporting to the Senior Quality Engineer, this role will be responsible for the upgrading and maintaining quality systems to meet the requirements of the European and US Medicinal Product and medical device requirement, this includes the establishment, maintenance and continuous improvement of quality systems, procedures and policies.
Keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact to the company and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions.
Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops. Monitor local Regulatory Environment and feed-back to relevant stakeholders
Liaise with Customers and regulatory agencies.
Management of customer documents into the Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
Maintain a comprehensive audit readiness program to ensure internal and external compliance for Medicinal Product lines and associated processes
Develop reports / presentations on the status of the compliance program for senior management team and the wider services colleagues.
Support the Medicinal Product transfer and validation of process and/or assembly lines from a customer or sites through QMS set-up to meet specification and ensuring an agile and compliant operational system.
Compile and review all relevant batch manufacturing and test data, including deviations and out of specification investigations, for final approval by the QP
Liaise with the QP on performance of the QMS and emerging quality trends and risks in order to drive quality improvements.
Adherence to incoming control requirements and supporting the SCAR process when required.
Lead Customer Complaint investigation to enhance preventive action and reduction of risk to customers and to our QMS.
Facilitate and lead risk assessments to ensure compliance and enhance QMS.
Conduct various Medicinal Product trend analyses to identify short and long range patterns so that recommendations can be made in order to effect continuous improvement necessary to satisfy customer requirements and drive improvements of QMS.
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all site Environmental, Health and Safety requirements, training and regulations.
Compliance to all local site company policies, procedures and corporate policies.
Perform additional duties at the request of the direct supervisor.
Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent with at least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
Knowledge of and experience of maintaining a QMS which meets the legislative requirement of human medicines and medical devices in the EU and USA and the ISO13485 standard.
Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971
Experience of hosting regulatory audits from either the European or US authorities.
Accredited lead auditor against recognised quality standards in support of internal and supplier audits
Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
Must have excellent written and verbal communication skills.
Preferred Knowledge, Skills and Abilities:
Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
Able to comply with the company’s safety policy at all times.
Able to always comply with the company’s quality policy.
Must be able to travel up to 5% of the time.
Physical and Mental Requirements:
Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.
For more information, please apply through the link provided for the attention of Daniel Kirwan or email [email protected] If you are interested in finding out more about the above role and would like to be considered other suitable roles that we may have available for your skill set – please attach your CV via the link provided Please submit your updated CV in Word Format If you are living in Ireland and hold a valid work permit, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Osborne are proud to be an Equal Opportunity Employer. Please visit www.osborne.iefor more information on all of our roles