Qualified Person

Adecco (Portugal); Waterford; Hybrid; EUR 85,000 - 120,000; Full time

Job summary

Adecco Portugal seeks an experienced Qualified Person to ensure the release of licensed pharmaceutical products in Ireland. You will lead batch disposition, ensure regulatory compliance, and participate in cross-functional quality teams.

The role offers hybrid working with initial on-site training, opportunities for advanced training, and a focus on continuous improvement in quality systems.

Qualifications

• Eight+ years of cGMP experience with QP responsibilities
• Postgraduate qualification (MSc or equivalent) required
• Experience as QP on a licensed site highly desirable
• Biologics manufacturing experience a plus
• Sterile manufacturing or Clinical Trials Regulations exposure a plus
• Strong training and mentoring experience
• Excellent oral and written communication

Responsibilities

• Manage batch disposition to ensure timely release of product.
• Ensure compliance with site practices and regulatory requirements.
• Support investigations and close deviations before batch release.
• Serve as Quality/QP representative on cross-functional teams.
• Provide QP support for quality issues as needed.
• Participate in internal committees and audits.
• Advise other departments on quality matters and independence of QP decisions.
• Foster partnerships to drive quality, compliance and continuous improvement.

Skills

Leadership

Communication

Problem solving

Risk assessment

Education

MSc or equivalent

Job description

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.

Main responsibilities:

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.

• 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:

Preference is a candidate to work 5 days per week.

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.

Requirements:

• Qualification requirements
• Experience of min. 2 years in a QP role on a licensed site
• Experience in pharma org
• Experience in batch release

Desired Skills and Experience

Qualified Person, Pharmaceutical Industry, Batch Release