Qualified Person

Qualified Person (QP)

• 3 days a week (22.5 hours)

• Hybrid with 2 days a week onsite

• Travel in UK and EU approx. once a month.

Were looking for an experienced Qualified Person (QP) to provide QP certification quality leadership and compliance oversight across Crinone commercial operations. Youll ensure batches are released in line with UK legislation cGMP and the Orange Guide while supporting projects audits and continuous improvement across the business.

The Role:

• Certify commercial batches in accordance with UK legislation and product licences.

• Ensure all manufacturing meets cGMP and Orange Guide requirements.

• Provide Quality compliance and regulatory guidance to the Crinone Quality team.

• Review BMRs deviations and key PQS processes (Change Control CAPA QA agreements etc.).

• Conduct internal/external GMP audits and support client/regulatory inspections.

• Oversee contractor and supplier performance through site visits and business reviews.

• Contribute to Product Quality Reviews and manage any Product Recalls.

• Support materials management risk assessments and QA leadership activities.

• Lead CI projects and ensure safe working practices.

The Candidate:

• Eligible to act as a QP with a sciencebased degree.

• Strong understanding of GMP Quality Systems for pharmaceutical manufacturing.

• Knowledge of EU/US GMP ICH and WHO guidance.

• Trained auditor with experience in client and regulatory inspections.

• Excellent communication organisation and stakeholder management skills.

• Proficient in Microsoft Office and able to work effectively under pressure.

Why You Should Join Catalent:

• Competitive Salary Reflecting your experience and skills.

• Bonus & Benefits Includes a site performance bonus a pension scheme matching up to 6% and 4 x life assurance. Enjoy private medical insurance a generous holiday entitlement that increases with tenure and the option to buy leave.

• Career Development Access high-quality training mentoring and cross-functional opportunities within Catalents global network. Benefit from a subscription to LinkedIn Learning providing access to 10000 online courses.

• Health & Wellbeing Includes an employee assistance programme on-site canteen facilities and an active safety and Patient First culture. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus participate in charitable activities.

• Excellent Location Just a few minutes drive from J26 of the M1 with free on-site parking. Commutable from Derbyshire Leicestershire and Nottinghamshire.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.