Senior Quality Associate

4 weeks ago

Swindon, United Kingdom Catalent Full time

The Senior QA Associate will work closely with Associate Director Quality - Product Development and represent the quality function at a senior level. They will attend project meetings, conduct reviews on project documents, manufacturing records and deviations, liaise directly with clients in the drafting of Quality Agreements, supporting client audits and generally ensuring the numerous development projects have the necessary steer and support from the Quality team. As part of the wider quality team, they will ensure all batches have met the requirements of their clinical trial dossiers where required and fulfil the requirements of technical agreements with customers.

The role:

- Pre-release review of batch records and project documentation ensuring GMP compliance
- To ensure the batch has been manufactured in accordance with the relevant GMP guidelines
- To ensure that Validation of the testing and manufacturing processes is complete and relevant.
- To ensure any deviations in quality procedure or manufacture are notified in accordance with the defined reporting system and investigated before any impacted batch is released. In addition, ensure that any additional sampling and inspection, tests and checks are completed in response to these deviations.
- To provide technical support to the team of QA officers and other key contacts including but not limited to production and quality personnel.
- To assist in the drafting and review of development batch manufacturing records.
- To review and approve SOPs, validation protocols and Change Controls in accordance with company procedures and guidelines.
- To perform and host audits (internal and external) as required confirming manufacture is in compliance with relevant GMPs.
- To assist in customer/regulator liaison, demonstrating our quality systems as required, and taking an active role when customers/regulators audit our site.
- To support investigations, root cause analysis and facilitation of other problem solving or risk ranking tools as required.
- Support with on-boarding of new drug substances and excipients as required.
- Experience of working with oral or sterile dosage forms is an advantage.
- Understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a pharmaceutical manufacturing environment is preferred.
- Good interpersonal skills with an ability to quickly establish and maintain excellent interpersonal relationships within all levels of the organization.
- Experience of working with development / IMP medicinal products

**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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