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.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 !!!
THE ROLE:
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
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 (phone hidden) or email: [email protected]
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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