Description
Pharmaceutical company is seeking a Quality and Regulatory Affairs Manager for their API site in Co. Wicklow.This is a varied, hands on role, the successful candidate will manage a team of up to twenty people across QC and QA, the Quality and RA manager will also be responsible for developing and menthoring the junior team members.
Day to Day:
-Responsible for managing the Quality function at the company. -Coordinate QC test and release activities, finished product, and intermediates to ensure product release to plan. -Manage analytical method transfer projects from the sites or from customers. -Prepare analytical validation protocols, review and approve reports. -Coordinate contract laboratories for QC, Micro.& Environmental testing. -Manage in-house and customer stability requirements for all API`s. -Primary point of contact for Regulatory bodies and customer related quality issues. -Manage and guide the activities of QA/QC staff to ensure compliance with regulatory requirements Totaling at 20 staff. -Deliver regular training to all staff via the Quality function. -Overall responsibility for maintaining and developing the site Validation -Master Plan and Quality systems. Schedule, manage customer audits; ensure timely response and close out. -Manage dept. budget while actively pursuing cost reduction opportunities -Perform internal, external audits (Supplier, Quality, Environmental, Corporate) as required. -Prepare, approve Technical and Quality agreements.
Requirements:
-Degree (Chemistry, Chemical Engineering, Pharmacy, Biological Science). -Significant experience of senior quality role in cGMP regulated environment. API experience essential.
An attractive salary and benefits package is on offer please contact me Anna Mooney for more information on the company and the role or reply with an up to to date CV and I will give you a call.