QP/QA Manager

CPL

Galway

QP/QA Manager - Permanent Job - GALWAY. Scope of the role: Responsible for the day to day management of the Quality Assurance department and co-ordination of all assigned elements of the Quality System. This role also encompasses the role of pharmaceutical batch release as a Qualified Person under EU guidelines. Through the implementation and oversight of an effective Quality management system, the QP will be accountable for efficient product flow and to ensure operational teams meet all product quality and compliance requirements to enable batch disposition. This will require the QP to be an active member of cross-functional operational teams providing independent Quality support, guidance and expertise to ensure the highest Quality and Compliance standards are adhered to. RESPONSIBILITIES. Manage the day to day administration of all required Quality Management System elements assigned in line with the appropriate current Quality policies/procedures and appropriate quality regulations. Perform QA/QP batch release as required to support operational business requirements (the job holder is required to be named on the site manufacturing licence as a QP and perform QP batch release as per current relevant EU guidelines. Provide direct leadership, mentoring and guidance to all relevant Quality Assurance staff to ensure excellent performance while maintaining a positive team environment. Provide QA input into relevant Risk Management programmes within the company and to utilise risk management tools to support science based decision making is support of the highest product quality, safety and efficacy standards. Develop and implement effective performance monitoring indicators for the Quality Assurance department. Actively participate in Material review boards, Product quality reviews, Site Quality Council and Quality management reviews. Operate alongside operational teams in the timely resolution of batch investigations, change management and in the implementation of operational excellence initiatives. Ensure Quality oversight and input to new product and process introduction on site. Identify and lead continuous improvement projects for the site as required. Work with cross-site teams as required to implement global quality policies and compliance improvement initiatives. Deputise for the Site Change Control Coordinator (Trackwise) when required. Deputise for the Senior Quality Assurance Manager as required. CRITERIA: Experience of all pharmaceutical/medical device quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release and management review. Experience of Quality Engineering and Lean operational systems in manufacturing is beneficial. Working management of risk management tools (eg. Hazard Analysis and Critical Control Points and / or Failure Mode Effect Analysis. EDUCATION. Minimum of a Bachelor's degree (or equivalent) in a science related discipline and previous experience in a Quality Assurance department in a pharmaceutical/medical device company is highly desirable. Previous experience in a sterile product manufacturing facility is highly desirable. 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.

2382 days ago