QA Systems Manager

Location: Harwell, OX11 0GD

The Role (daily responsibilities)

Ensure the maintenance and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidances and Catalent policies/procedures.
Ensure the appropriate support to Quality Assurance Director regarding the design, effective implementation, monitoring and maintenance of the quality management system
Update, in compliance with the current regulation the QA quality system documents.
Update the Site Master File and the Drug Master File
With the collaboration of concerned department, establish annually the Annual Quality Review (AQR).
Subject Matter expert covering QA questions, related to QA system, by customers, internal teams or during external audit.
Review, challenge and approve, in compliance with GMP, Deviation, CAPA, Complains, Audits, Change Control, Risk Analysis quality system documents.
Identifyy and determine quality improvement and recommend appropriate solutions.
Update and take adapted action to maintain of deviation, CAPA, change control, risk analysis with KPI.
Review data analyse results and recommend changes based upon findings and perform follow up to verify effectiveness.
Ensure that the required initial and continuing training of the QA department personnel is carried out and adapted according to need.
Ensure the internal audit program is compliant to current regulations as required.
Plan, coordinate (scheduling, and reporting) and perform audits of the plant systems and procedures.
Ensure to have Risk Management quality system documents up-to-date.

The Candidate (requirements)

Bioengineering degree or master’s degree in biology, pharmacy, clinical chemistry, etc., or relevant experience in a similar position in the sector of biotech/Pharma/cell therapy.
Good knowledge of cGMP
Experience of minimum 2-3 years in Quality Assurance, preferably in a biopharmaceutical company
Experience in cGMP audits
Knowledge of medical devices is a plus
Experience in cell therapy or quality control of human cells is a plus

Leadership Competencies

Leads with Integrity and Respect
Delivers Results
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Champions Change
Engages and Inspires
Coaches and Develops
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.

Application Instructions: 

Click here to apply: https://bit.ly/3RtGMBA

Application Closing Date: 
31 December 2022