QP Coordinator

2 days ago

Bathgate, United Kingdom Disability Solutions Full time

Catalent Pharma Solutions are seeking an experienced Qualified Person Support Specialist. This role will see you Liaise with the Qualified Person, external Catalent sites and clients to collate and file batch documentation to a required standard that enables the QP to review and sign off.

The Role

  • Attend study set up/change of scope meetings to set up/support QP certification requirements.

  • Review documentation relating to receipt of Finished Products to ensure compliance with project and client requirements and perform Quality release for distribution.

  • Support the filing of and updates of QP study documentation.

  • Maintain supply, chain information to allow tracking of site audit requirements.

  • Liaise with the QP following an external audit and support audit follow up activities including filing of audit information.

  • Oversee the QP group mailboxes and action accordingly.

  • Review and approve Material Specifications to ensure compliance with project and client requirements.

  • Review and approve deviation reports to ensure compliance with GMP.

  • Prepare MIAS QP IMP, NIMP & Bulk certificates.

  • Preparation of MIAS shipment temperature excursion reports

The Candidate

  • 5 years or more experience of Pharmaceutical/Clinical Trials Packaging and /or GMP Processes or equivalent.

  • 5 years or less experience of Pharmaceutical/Clinical Trials Packaging and /or GMP Processes or equivalent with relevant training completed.

  • Excellent verbal/written communication skills.

  • A high level of concentration and attention to detail is essential.

  • The ability to prioritise daily/weekly workload.

  • Ability to work independently.

  • Strong analytical and problem-solving skills

  • The ability to be decisive when required on material/product quality issues to ensure compliance.

Position Benefits

  • Annual bonus

  • Pension

  • Life Assurance

  • Healthcare

Catalent offers rewarding opportunities to further your career  Join the global drug development and delivery leader and help us bring over 7,000 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 DisabilityAccommodations@catalent.com. 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.