Location: Harwell, OX11 0GD
The QA Validation Manager is responsible for setting the Site Validation strategy and ensuring technical validation oversight of facility qualification and start up in accordance with Catalent Standards and Policies.
The QA Validation Manager is a partner to the Operations and Engineering Departments.
The Role (daily responsibilities)
The QA Validation Manager is responsible to implement and maintain the validation system including the computer system validation (CSV), data integrity (DI) and sterility assurance (SA) aspects as applicable.
The QA Validation Manager is an active member of QA management team and will lead a team of QA Validation Supervisor/Specialist/Officer(s).
Ensuring the appropriate support to Quality Assurance Director regarding the design, effective implementation, monitoring and maintenance of the quality management system related to validation.
Establishing Key Performance Indicators and trends regarding the team’s activities and he must report potential and confirmed budget deviation.
He/she vehicles Catalent and QA chart values, QA department vision and mission.
The QA Validation Manager is responsible to implement and maintain the following quality systems:
The QA Validation manager is taking in charge of all validation/CSV/DI/SA aspects in the project related matters in the Catalent organization.
Update the Site Validation Masterfile and other SOPs linked with validation/CSV/DI/SA aspect for initial use and maintaining the validated status
Provide QA Validation support of change control process to ensure execution are compliant with internal policies and procedures for validation/CSV/DI/SA aspects.
Provide QA support, including review and approval, for deviations and investigations related to validation/CSV/DI/SA failures ensuring events are contained, risks mitigated, impacts to equipment, product and processes adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented.
Ensure that the required initial and continuing training of the QA Validation team is carried out and adapted according to need.
Supervise the activities of the QA Validation team to achieve their goal.
Perform self-inspections & ensure QA on the floor.
Develop the mindset of continuous improvement culture
Identify and lead continuous improvement projects
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 quality tools:
Handling regulatory inspections
Well acquainted with Change control/ deviation and market compliance management system
Experience of minimum 5-7 years in Quality Assurance, preferably in a biopharmaceutical company
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
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.
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