A vacancy has arisen for the position of Quality Assurance Manager, reporting to Quality Manager.
Responsible for ensuring that robust and compliant systems are in place for QA oversight including review, monitoring, reporting of Quality Systems trends by actively participating in the review and approval of complaints, deviation, change controls etc.
Assuring that the appropriate documentation is in place as per cGMP guidelines and corporate policies.
Involvement in the preparation, support and follow-up of Regulatory Agency inspections including HPRA, TUV Regulatory Agencies, and Corporate & Strategic Partners as well as performing internal audits as required.
Adheres to all cGMP compliance and regulatory mandates and quality requirements, and complying with all SOPs and internal policies and procedures in the performance of job duties.
Responsible for the safe, compliant, and efficient execution of job duties in a team environment.
Responsible for management of supplier qualification process including performance of supplier audits.
Experience in the following areas is required:
Good Manufacturing Practice and Good Laboratory Practice (GLP).
Review and approval of QMS related documentation for compliance with GMP
Preparation for and participation in both customer and regulatory inspections, including post inspection follow up.
Preparation of Annual Product Quality Reviews.
Change Control management
Process Deviation Report management including implementation of effective corrective actions
Managing Customer Complaints ensuring all complaints are addressed promptly & thoroughly
Monitoring of supplier performance and evaluation / auditing of suppliers and potential suppliers
Management of GMP documentation
Preparation and approval of standard operating procedures (SOPs)
Final quality review of batches prior to release by a Qualified Person
Management of recalls and the generation of mock recall reports
Induction GMP training and training plan preparation
Experience in maintenance of an ISO 13485 QMS for medical devices is desirable but not essential.
Experience in implementation of continuous improvement initiatives
EDUCATION & QUALIFICATION
A primary degree in life science or another related field
A Postgraduate qualification which allows the candidate to act as a Qualified Person (preferable)
A minimum of 5 years working in a similar role or at a supervisory level within quality assurance
Ability to work both alone and as part of a team
High attention to detail
A good understanding of regulatory requirements.
The ability to interact internationally with HQ and other group sites
Excellent oral and written communication skills.
Experience in performance management and personnel development
For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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|Job Title:||QA Manager|
|Contact Name:||Laurentina kennedy|
|Job Published:||over 4 years ago|