Deviation & Compliance Specialist - Swindon, United Kingdom - Catalent

Catalent

Verified Company

Swindon, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Deviation and Compliance specialist

Do you want to join a high performing team in a global pharmaceutical company that invests in its people to help them develop and progress? Our number one value is Patient First.

Everything we do surrounds this philosophy, and we see our employees as our primary asset when it comes to achieving this essential business value.

The Deviation and Compliance team are based within production department and provide support to the operations team in all aspect of deviation and compliance.

We are looking for a
Deviation and Compliance Specialist to join this team.

The role;

To ensure that Batch progression is maintained by expediting to closure all Deviation records (including manufacturing investigations and justified customer complaints).
To form part of a cohesive mentoring team for Operation personnel by providing assistance and advice on initial Deviation RCA completion
Ensure daily reports are generated and briefed to Operations team to highlight current state of Deviations through the Trackwise workflow
Day to day management of Deviation flow throughout the Zydis manufacturing department, to ensure batches are expedited to QA/QP review in line with the daily requirements of the batch tracker
Be Primary contact for all Deviation activities ensuring a complete resolution is found via correction or implementation of appropriate preventative measures
Be Customer contact (alongside relevant QP / QA associate) for all customer questions / concerns with regards to deviations
Provide expert process knowledge to Operation teams to help assist with deviation data gathering (RCA / Tripartite)
To proactively identify opportunities for process improvements

The Person

Experience in report writing advantageous
Contract manufacturing experience advantageous
Ability to multitask and demonstrate diplomatic skills across the functions
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 effectively present information and respond to questions from peers, management, suppliers and customers
Strong organizational skills
Ability to work effectively under pressure to meet deadlines
Report writing
This is an onsite role, working within the production floor where PPE is worn.

Positions Benefits

Salary
Pension
Site bonus
Holiday Entitlement

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.