QAo Section Head - Swindon, United Kingdom - Catalent

Catalent

Verified Company

Swindon, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

An exciting opportunity has arisen for a Quality Assurance Officer Section head to join our busy quality team at Catalent Pharma solutions Swindon.

The Swindon facility houses our Zydis fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services.

This quality role is situated in the production facility.

You will be part of a small, but extremely functional team of individuals which is an eclectic mix of talent and experience.

You will be joining a fast paced manufacturing environment with complex processes.

The QAO Section head will coordinate activities within the Quality Assurance group at Catalent, Swindon, in order to build in and demonstrate an assurance of quality for manufactured products, in accordance with the principles of cGMP.

The role:

Work closely with QA Operations Manager to ensure QA batch review is performed in a timely manner to meet internal and external customer requirements.
To deputise for QA Operations Manager and represent the site's QA department in a capacity commensurate with a senior position.
Limited supervisory responsibility for QA Officers, including performance management and supporting staff in attaining their personal development plans.
To ensure reportee QA Officers are trained appropriately for their duties and that all training is documented.
To perform batch documentation and deviation review, liaising with production management to resolve and clarify any points of issue.
To support and help drive continuous improvement activities within the team.
To participate in internal and external audits related to QAO activities. Assist in customer/regulatory audit preparation.
To provide support, as necessary, to the wider Quality team with activities relating to batch release. Able to participate in customer meetings.
To conduct selfinspection audits of the production area and specific site systems in accordance with the agreed schedule.
To assist coordination of 24/7 Quality cover of Zydis Production.
To perform other duties as may be required from time to time by the line management.
Experience working within a GMP environment
Quality experience including audits & Reviewing Batch records
People management experience

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.