Description
A Pharmaceutical company that Produces and sells a broad range of biochemicals, organic and inorganic chemicals and related products, is seeking a QA and RA Manager.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
*Act as primary point of contact for FDA, IMB, and other regulatory bodies, as well as for customer audits, technical visits and other quality related issues.
*Responsible for organizing and leading plant's responses to quality audits by customers and regulatory agencies.
*Lead and train staff in robust root cause analysis investigations to compliment and aid closure of deviations and complaint resolution to prevent re-occurrence.
*Final decision point on site for all quality related issues and ultimate responsibility for the overall release of products ensuring quality and regulatory requirements are met.
*Any other duties as may be reasonably requested from time to time.
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.