Job Descriptions

A snapshot of your key responsibilities as a Validation Team Lead would be:

• Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
• Generation, maintenance, and execution of Project Validation Plans and schedules
• Generation of validation protocols and final reports to cGMP standards.
• QA support for validation investigations and implementation of corrective actions.
• Creation, review, and approval of various validation and qualification documents.
• Management of validation, exception event, and change control processes.
• Documenting all activities in line with cGMP requirements.
• Performing cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
• Coordinating activities to maximize the effectiveness of all of the team members.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Education and Experience:

• Bachelors/Masters degree in engineering or relevant scientific discipline
• 3 years plus validation/quality experience in sterile/aseptic environment, especially in the commissioning and qualification area
• 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.  
• 3 years plus of leadership experience.
• A minimum of 3 years’ experience in a cGMP regulated environment.
• Strong communication (written and oral), presentation and troubleshooting skills required
• Effective interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Capable of prioritizing work and multitasking.
• A minimum of 3 years’ experience in a cGMP regulated environment.

Skills

• Interpersonal Skills
• Organisational Skills

Experience

• 3+ years