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Job Details

QA Specialist Medical Devices

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD9178
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a QA Specialist

Requirements:

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a QA Specialist 

Purpose:

  • 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
  • Coordinate customer complaint system
  • Completion of Deviations and Change Control in partnership with the other departments
  • Managing Project, where required
  • Monitoring trends in product quality parameters, Deviations and Change Control developing proactive recommendations to maintain company’s performance under control

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 company 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) company is responsible for.
  • Provides oversight for the analysis of Customer Complaints and reporting for company and assures timely completion.
  • Authors and ensures timely completion of Change Controls, Action Requests, and Change Control related commitments
  • Carries out SME role on QA aspects of process owned by company.   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  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 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.
  • Managing Project, where required
  • Adherence to Company Health & Safety procedures
  • Participate in training programmes

Requirements
-Min 2 years experience in a similar QA role within the pharmaceutical, or related sector
-Relevant Degree or equivalent qualification in science

Apply for this job: QA Specialist Medical Devices

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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