QA Validation Supervisor

Team Horizon currently has an exciting opening for a QA Supervisor on a 12-month contract for our Clients Validation group at their Dublin based manufacturing facility. The QA Validation Supervisor will be responsible for the supervision of the QA Validation team as well as for staying current with proposed and implemented regulations and understanding industry trends.  This position interfaces and collaborates with corporate and other site Departments assuring that the site is fully compliant with IMB, FDA and corporate standards.  The QA Validation Supervisor is a key participant in site regulatory agency and Corporate inspections.  This position supervises a team of Technicians and Specialists and reports to the site Associate Director for QA.
 
 
Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.


• The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.


• Excellent career progression opportunities.

 
What you will bedoing:

• Maintaining system availability


• Provide Support and guidance for the Quality Validation Team.


• Work with Planning, Production, QA Production Support, QA Systems, QC, QP, and Materials Management to establish priorities; communicate issues and resolve issues; and communicate progress.


• Cross train QA Validation team on the various processes.


• Supervise key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews, Internal Auditing, Regulatory audits, Corporate audits, Site Quality Reviews, Document Management and Control, Technical Agreements and Site Master File. 


• Measure, report and trends site performance on key indicators of these quality systems through metrics.


• Ensure quality system performance is appropriately and well communicated throughout site.  Provide guidance and assessments to the site Quality Validation Team.


• Ensure site compliance with Irish Medicines Board, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate.


• Supervise and direct all deviation investigations.


• Develop a support/service mentality in Quality staff, partnering with local site departments.


• Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines.


• Seek process innovation and continuous process improvement in QA function.


• Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations.


• Allocate and coordinate personnel resources to all QA compliance activities and provide direction to ensure that specified targets for team are met.


• Maintain accountability for own team’s performance metrics that support the annual operating plan and site strategic plan objectives.


• Ensure data reports on own team’s performance are current, accurate, and distributed according to defined procedures.


• Contribute to the continual improvement of QA documentation and ensure that they are current, accurate, and clearly define process and role responsibilities.


• Provide hands on training, support, and coaching to reports.


• Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership.


• Complete and conform to all training requirements for job role, including company-required and job role-specific training.

 
 
What you need to apply:

• You will have a relevant a third level Bachelor’s Degree in Chemistry or related Science discipline


•  3-5 years’ experience in a similar role working with pharmaceutical processing technologies with preferably some of this experience in Quality Assurance.  


• Good understanding of 21CFR / cGMP documentation and electronic systems requirements.


• People management Experience in aligning individuals and teams to business objectives


• Exposure to Lean manufacturing concepts


• Experience in managing by metrics