Q.A. Qualified Person

A Quality Assurance Qualified Person is required by CareerWise Recruitment for our Galway based client. The Q. A. Qualified Person is responsible for delivery of quality assurance activities to ensure commercial products are manufactured in accordance with cGMP, corporate and regulatory requirements. This role also encompasses the role of pharmaceutical batch release as a Qualified Person under EU GMP 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.

THE ROLE:

• 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 of pharmaceutical products to the market in accordance with guidelines of Annex 16 of EU GMP guide and relevant legislation 2001/83/EC & 2001/82/EC.
• Responsible for the release of medical device finished products to market as per relevant approved procedures.
• Provide technical expertise for all QA and compliance topics/issues as required.
• Provide QA input into relevant Risk Management programmes within the company and to utilise risk management tools to support science based decision making in support of the highest product quality, safety and efficacy standards.
• Assist with development and implementation of effective performance monitoring indicators for the Quality Assurance department.
• Perform timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
• Provide support for deviation investigations, including root cause analysis and corrective and preventative action (CAPAs) proposals and initiatives.
• Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Actively contributes to continuous improvement activities.
• Work with cross-site teams as required to implement Corporate Global Quality policies and compliance improvement initiatives
• Deputise for the Quality Assurance Operations Manager as required

REQUIREMENTS:

• Minimum of a Bachelor's Degree (or equivalent) in a Science related discipline.
• Minimum of 5 years relevant experience within the Pharma industry or a related field.
• Previous experience in a Sterile Product Manufacturing facility is highly desirable.
• Must be eligible for Qualified Persons status as per EU guidelines.
• 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.
• Ability to handle multiple tasks in a fast paced environment.
• Experience of Quality Engineering and Lean operational systems in manufacturing is beneficial.
• Working management of risk management tools (e.g. Hazard Analysis and Critical Control Points and / or Failure Mode Effect Analysis
• Excellent communication and interpersonal skills.
• Positive attitude with an innovation mindset.
• Self-starter with demonstrated efficient work methods and excellent initiative.
• Demonstrated people management skills a distinct advantage.
• Proven success in a team environment, e.g. project teams, operational excellence team.
• Excellent communication and presentation skills with a hands-on approach to team leadership.
• Candidates should be self-motivated with the ability to work on their own initiative and should possess excellent organisational and time management skills.
• Ability to manage requirements of multiple decision makers, corporate colleagues, auditors, cross functional teams by building strong relationships at all levels.

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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