Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 300 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).
The QA Administrator role is a very important role within the QA & Compliance department of Pinewood Healthcare. The Quality Assurance Administrator is responsible for ensuring that all documentation are issued, controlled, retrieved and archive appropriately and is compliant to cGMP. The role holder will have a strong attention to detail. The position works in supporting key stakeholders like site manufacturing and quality assuring compliance to the Quality Management System.
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To manage, distribute and scan all documentation within the quality department.
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Arrange training and manage and maintain the training matrix, SOP's and training records.
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Record and amend SOP's and manage the SOP during the approval process.
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Assist in maintaining and updating the Approved supplier list
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Applications for Controlled Drugs Licenses and registrations
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Communication of Global Policy and Procedure Updates
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Maintenance of the Methadone Pharmacy List
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Assist with the Maintenance and Development of the quality department.
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Handling of customer queries received.
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Manage and maintain trends and metrics
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Control and issuing of documents including but not limited to SOPs, Logbooks, Training Records
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Report writing (Experience in Microsoft).
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Generation of new codes and implementing changes on SAP
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Coordination of complaint sample return via courier
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Generating packaging specifications in preparation for production.
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Generate and maintain quality schedules
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Medical device administration & generation of product Specification File.
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Participate in the monitoring and maintenance of temperature devices and documentation
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Arrange periodic pest control site visits and accompany external pest control personnel while on site
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Raising of Purchase Orders and parking invoices for the Quality department
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Completion of external Quality questionnaires
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Any other duties as deemed appropriate and as designated by the Manager
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Computer literate, competent with excel. SAP knowledge desirable.
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Must be able to work as part of a team and on own initiative.
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Good communication skills.
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Excellent attention to detail.
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Good Time Management skills.
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Team player
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Compliance to all policies, procedures, ethical standards and processes.
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Act as a key communicator ensuring that all information is appropriately communicated through the quality team.
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Outstanding organizational and time-management skills.
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Exceptional ability to leverage/collaborate effectively with internal and external stakeholders.
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Excellent written and verbal communication and interpersonal skills.
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Comfortable working in a busy, fast paced regulated manufacturing environment
