Gmp Document Coordinator

2 days ago

Nottingham, United Kingdom Catalent Full time

Catalent are currently recruiting for GMP Document Coordinator to join the technical support department. The document controller will be accountable and responsible for ensuring that all activities required for the preparation of GMP manufacturing steps are complete in readiness for the planned work in accordance with the requirements of the management systems.

The job:

- The preparation and approval of all technically derived GMP manufacturing documentation whether directly or indirectly required to support the creation of or execution of the related records.
- The preparation of commercial and clinical trial documentation related to the manufacturing of products to a high standard of quality in accordance with current Good Manufacturing Practice (cGMP) across a full range of dosage forms.
- Liaising directly with Programme Technical Support Leads, Study Directors and clients to ensure optimised transfer of critical technical information to ensure smooth and seamless transition of manufacturing processes from Formulation Development to GMP manufacturing.
- Working closely with the Project specific cross functional teams to ensure timely and accurate preparation of supportive Quality Risk Assessments, Cleaning Technical Assessments, and training packs that are in place prior to onset of GMP Manufacturing activities.
- Training the manufacturing team in study specific batch record completion.
- Raise and execute quality system documentation (e.g. deviations and change controls) in line with agreed procedures’ and project specific requirements.
- Maintain personnel training record at all times and proactively identify any training requirements for the job role.
- Demonstrate a high level of flexibility to support the business needs and our client’s requirements.

The role:

- Ability to multi-task and demonstrate diplomatic skills
- Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization
- Ability to perform to a high standard in a fast-paced and highly regulated GMP Manufacturing environment
- Strong organizational skills
Ability to work effectively under pressure to meet deadlines
- Strong GMP Compliance
- Excellent numerical skills
**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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.

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