QA Compliance Specialist

CPL

Mayo

QA Compliance Specialist. Job Summary. Management of the deviations program including all commercial and validation stability deviations. Organization of meetings with specific sites and Business Units regarding deviations generated on both commercial and validation studies. Compile agency investigation reports and coordinate notifications to regulatory agencies. Track status of open investigations. Hosting the monthly meetings with the committee in order to make decisions with relation to the storage conditions for these regions. This person will also act as technical reviewer for global change controls associated with stability shelf life determinations. Management of the work performed by the technicians creating and processing stability deviations with feedback to the compliance lead on performance. Verification that project leaders have been informed of all stability failures associated with validation stability studies. Communicate Key Performance Indicators as they pertain to number of open stability deviation (Commercial and validation. Hold progress meetings with relevant team members. Actively participate in the training and certification of new team members. Ensure that all aspects of the area of responsibility are fully staffed and that any constraints are managed appropriately. Ensure all activities are completed in line with regulatory (QA and EHS) and corporate requirements. Provide required data to support stability deviation investigations and site decision making processes. (Technical data provider. Provide team KPI data. Attend Departmental and APEX meetings (as appropriate. Any other meeting as directed by the Lead or Area Managers. Provide review and approval of local and corporate documents. Work directly with the other laboratories to ensure that the stability deviation program is up to date at all times. MAIN CONTACTS: Compliance Lead. Laboratory Testing Leads. Technical Manager / Analytical Lab Manager. Business Unit contact (where relevant. Site QA. Global QA. Regulatory Affairs department. Regulatory bodies. KEY REQUIREMENTS. Education and Experience/Knowledge: Proven track record in project management. Scientific qualification in relevant discipline. Knowledge of laboratory GMP standards. Ability to articulate clearly when dealing with external bodies. Goal orientated – need to drive deviation investigations to completion. Interested candidates please contact Annette Murphy on 091 507515 or email your CV in confidence to annette.murphy@cpl.ie. This job originally appeared on RecruitIreland.com.

2557 days ago