Quality Assurance Manager
|Job Title:||Quality Assurance Manager|
|Contact Name:||John Reid|
|Job Published:||almost 2 years ago|
My client a leading Multinational Healthcare Manufacturing company now require a Quality Assurance Manager to join their expanding team.
This is a permanent role based in Dublin and it comes with a very good salary with good benefits.
Responsibilities of a Quality Assurance 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, 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
? 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
? 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
? 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.
Requirements of a Quality Assurance Manager
? A minimum of 5 years working in a similar role or at a supervisory level within quality assurance
? A primary degree in life science or another related field
? A Postgraduate qualification which allows the candidate to act as a Qualified Person (preferable)
? Ability to work both alone and as part of a team
? A good understanding of regulatory requirements.
? The ability to interact internationally with HQ and other group sites
? Experience in performance management and personnel development
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below
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