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QA Specialist

Ref: 920274

  • €40,000 - €42,000
  • 15 Apr 2019
  • Dublin (West)
  • Perm

Partners with the Regulatory Affairs, Supply Chain and Pharmacovigilance to assist and participate in the assurance of compliance activities required to ensure that products supplied are in accordance with cGMP their associated Marketing Authorisation, standards and values. The incumbent is accountable for the following functions within their respective manufacturing cell: • Ensures relevant regulatory information is available for product release • Liaising with local and external affiliates to ensure regulatory compliance at manufacturing sites is maintained. • Initiating and managing regulatory compliance remediation activities to ensure registered information complies with manufacturing site practices • Participation in process improvement projects providing direct QA support throughout project execution • Completion of Deviations and Change Control in partnership with the other APTL departments • Monitoring trends in product quality parameters, Deviations and Change Control developing proactive recommendations to maintain APTL’s performance under control Job Duties: Deviation/Change Control/Regulatory Compliance • Ensures relevant regulatory information is available for product release • Liaising with local and external affiliates to ensure regulatory compliance at manufacturing sites is maintained. • Initiating and managing regulatory compliance remediation activities to ensure registered information complies with manufacturing site practices • Initiates, authors, and possibly assist in approvals of deviations ensuring they contain the essential elements necessary to assure continuous product and process compliance and improvement in APTL performance • Assures completeness in terms of root cause, action taken, and preventative measures • Authors, tracks, and/or ensures timely closure of commitments (Regulatory Agency, investigation, audit, PQR, and other) APTL is responsible for • Provides oversight for the analysis of Customer Complaints and reporting for APTL and assures timely completion • Authors and ensures timely completion of Change Controls, Action Requests, and Change Control related commitments for APTL • Carries out SME role on QA aspects of process owned by APTL. Participates in SOP preparation as such. • Facilitates the management of the PQR process as required Monitoring Trends • Monitors trends in quality parameters presenting recommendations to the APTL management to maintain process under control and/or to further improve the process • Utilizes systems (e.g., Trackwise,) and applies tools (i.e., SPC, Six Sigma, DMAIC) to prepare trend reports Participation in Process Improvements • Applies cGMP knowledge to recommend action plans to the APTL teams supporting process improvements • Provides data on quality parameters, Deviations and Change Control trends to support continuous improvement • Links with the quality management to facilitate the implementation of Group wide initiatives • Adherence to Company Health & Safety procedures Candidate Profile: • Results and performance driven – deliver results that meet or exceed expectations • Sense of urgency – responding to issues and opportunities in a timely manner • Ability to lead and support several concurrent projects/products and develop strong relationship within cross-functional teams. • Be able to work autonomously and have good problem-solving skills • Highly driven with enthusiasm to meet role requirements and to cope under demanding pressure • Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business • Ability to influence and partner with cross-site teams in a global pharmaceutical To apply for this QA Specialist role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email m.bentley@brightwater.ie