Are you an experienced Quality Assurance Manager with biotech/pharma experience?Quality Assurance Manager - Pharma - DublinEmployerOur client is an international pharmaceutical company with a manufacturing plant in DublinThe plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description?Good Manufacturing Practice and Good Laboratory Practice (GLP).Review and approval of QMS related documentation for compliance with GMPPreparation for and participation in both customer and regulatory inspections, including post inspection follow up.Preparation of Annual Product Quality Reviews.Change Control managementProcess Deviation Report management including implementation of effective corrective actionsManaging Customer Complaints ensuring all complaints are addressed promptly & thoroughlyMonitoring of supplier performance and evaluation / auditing of suppliers and potential suppliersManagement of GMP documentationPreparation and approval of standard operating procedures (SOPs)Review of batches prior to release by a Qualified PersonArchiving of batch documentation and reference samplesManagement of recalls and the generation of mock recall reportsInduction GMP training and training plan preparationExperience in maintenance of an ISO 13485 QMS for medical devices is desirable but not essential.Experience in implementation of continuous improvement initiativesOther duties as required and as directed by the Quality Assurance Manager.
Requirements A primary degree in life science or another related fieldA Postgraduate qualification which allows the candidate to act as a Qualified Person (preferable)A minimum of 5 years working in a similar roleAbility to work both alone and as part of a teamHigh attention to detailA good understanding of regulatory requirements.
The ability to interact internationally with HQ and other group sitesExcellent oral and written communication skills.Experience in performance management and personnel development PackageSalary details on requestHealth Insurance paid by the employer after 12 months service for the employee only.Pension - After 6 month's service, you have the option of contributing 5% of salary to company pension scheme and company match with 5%.Annual Performance Related bonus.Annual Leave – 21 days per year at outset.
(Option to buy 3 further days)Educational Funding - 100% funding for further educational courses after 12 months service.Life Assurance - Death in service benefit provides for an amount payable equal to 4 times your salary.Recognition Awards – All Star Awards are awarded each quarter.Employee Assistance Programme.Subsidised canteen.Sports and Social.Free ParkingContactKaren McHugh is the consultant managing this position.If you have any queries about this role, you can contact Karen by e-mail ****** or call +353-1-7978720Click to connect with Karen on LinkedIn