- Reference: AJ43649
- Job Type: Permanent
- Location: Galway, Roscommon, Westmeath
- Category: Medical Devices
Responsibilities with the QA/RA function
REGULATORY AFFAIRS activities:
- Responsible for compliance of Medical Devices as per Ireland and European Medical Device Regulations.
- Provide documents to Head Office/Customer as assigned by VP – Regulatory Affairs and Product Development (Corporate)
- Proactive Communication to Regulatory Head about change in local regulation/policy that can affect business.
- Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
- Interpret existing and/or new regulatory requirements/Standards as they relate to company products and ensure timely compliance.
- Responsible for preparation and Updation of Technical Master Files
- To solve and reply regulatory query.
- To co-ordinate with regulatory agencies for audit and compliance.
QUALITY ASSURANCE activities:
- To Design, Develop and implement of QMS.
- Responsible for designing, updating, approving and implementation SOPs for Roscommon facility.
- To Conduct Periodic Self Inspections/Internal Audit and MRM (Management Review Meetings).
- To implement,handle and approve NCR, incident, Market Complaint, CAPA and Change control, Deviation, OOT, OOS Management.
- To monitor cGMP in line with standard procedure.
- To prepare RA, DQ, IQ, OQ &PQ and ensure activities as per defined protocols.
- Responsible for facing Regulatory audit and its compliance.
- To coordinates with external agencies for calibration and validation activities.
- To coordinates with inter department of implementation of QMS effectively.
- To approve validation protocol, SMF, VMP, QM and other apex documents.
- To approve RM / PM/ FP/ and stability Specification and Method of Analysis.
- To conduct Quality Risk Management of equipment, process and system.
- To involve in calibration and validation activities of lab instruments and equipments.
- Responsible for entire SAP related activities.
For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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