Qualified Person

€90 - €110.00 per hour subsidized canteen, gym, parking, H

Jenn at Wallace Myers is recruiting a contract QP for my client in Waterford

Ltd contract - 12 months

Full time : 5 days per week

Qualified Person Our Team:

The Quality Assurance team is made up of QP's, Managers, Technical Leads, Team Leads and Quality Specialists, all of whom are dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options to millions of people globally. Being part of this team will allow you to work in a state-of-the-art sterile filling facility. We produce both commercial and clinical products, with a very robust pipeline. And it is because of this we are looking for more quality professionals to join our expanding team.

Main responsibilities:

• 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

About you

• 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

Remote Working:

Hybrid working available

The expectation is full time on site for the first few months to complete training and get to know the site. Would like candidates to work 5 days per week.

For the hybrid model we would expect the QP to travel to site max 3 days per week.

All applications will be treated with the strictest of confidence

Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see wallacemyers.ie/privacy-policy