Qualified Person

A Qualified Person is required by CareerWise Recruitment for a 12-month contract position with our Waterford based pharmaceutical client. The Qualified Person is responsible to ensure that licensed product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16. This role requires you to be 3 days on site. You will be  part a team  that will allow you to work in a state-of-the-art sterile filling facility. Our client produces both commercial and clinical products, with a very robust pipeline why not be part of this excellent organisaton apply below !!!

Role of this position

• Manages the batch disposition process to ensure timely release of product
• Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
• Support major investigations, ensuring all product deviations are closed prior to batch release
• Participates in cross functional teams as Quality/Qualified Person representative
• Provide additional QP support to quality related issues, as the need arises
• Participates on internal committees/teams, as required.
• Provides advice and direction to other departments on quality issues.
• Ensure independence of the QP on decisions on quality related matters.
• Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
• Provide audit support as required for internal auditing program and supplier audits.
• Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice

JOB REQUIREMENTS

• Preference given to candidates with advanced degrees; eight or more years of cGMP experience preferred with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA) ; consideration will be given to other relevant experience and education
• Proven leadership skills comparable to 2+ years of management responsibility.
• Post Graduate Qualification required (MSc or equivalent)
• Biologics manufacturing experience highly desirable
• Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable.
•  Excellent training/mentoring experience
•  Excellent oral and written communication skills
•  Competent problem solving, risk assessment and impact analysis abilities

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@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. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.