Description
A pharmaceutical company based in Co. Wicklow is seeking a QA/RA Manager to join their team in their Arklow site.Day to Day:
*Ensure compliance with all quality regulations in a manner consistent with continued plant profitability.
*Co-ordinate and prioritise all quality compliance and auditing activities on site.
*Manage department budget in line with expectations, as well as regulatory spend within AOP, pursuing cost reductions in all possible areas.
*Ensure competence and motivation of all QA/QC personnel by clearly outlining expectations, training appropriately, setting objectives, managing performance and long term development of staff.
*Participate fully as a member of the Arklow Leadership Team, assisting with the determination of future strategy and goals.
*Ensure that all policies and procedures comply with cGMP requirements. Maintain thorough and up-to-date knowledge of relevant regulatory requirements (FDA, cGMP, customer and other relevant regulatory bodies); ensure that all relevant requirements and updates are communicated in a timely manner to all appropriate departments onsite.
*In close co-operation with the Operations Manager, oversee resolution of any customer related quality issues; verify implementation of corrective actions to address all production issues that contribute to out-of-specification batches.
*Develop and manage the site Validation Master Plan in accordance with regulatory and corporate requirements
*Review and drive compliance of site Quality Systems to ensure they fulfil the requirements of all relevant corporate policies
Essential:
*Degree (Chemistry, Chemical Engineering, Pharmacy, Biological Science).
*Significant experience of senior quality role in cGMP regulated environment.
Desirable:
*Six Sigma Plus Green Belt, or ability to become certified within one year
*QP or equivalent.
The role includes an attractive salary, and benefits package. For more information on the company and role please apply below with an up to date CV or call me Anna Mooney .