Validation Manager - #1696900

Validation Manager

Sumary:

Overall responsibilty for delivering all Validatioon requirements relating to the Capacity Expansion project. This will incluide creating the Validation Masterplan for the project, in line wirh the local and global business needs, aligned with the on site Validation team.

Responsibilities:

• Deliver all scheduled activities required on each given day,through effective and concise communication with team members, and ability to listen and discuss ideas in an open and professional manner.
• Provides support and mentorship to Validation staff, and other members of staff, on professional or Technical / Scientific topics.
• Respobsible for writing and review of all validation deliverables / SOPs / any Validation related documentation.
• Provides clear procedural and documentation training and expectations to staff members with an emphasis on quality and efficiency in order to deliver data (right first time) for Validation Projects.
• Develop training materials and delivers training/mentorship of staff in relevant techniques, procedures and provides expert advice on training requirements. Delivers appropriate trainings for staff before scheduled activity.
• Reviews work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.
• Ability to implement an action plan for solving project or technical problems as they occur.
• Independently reviews scientific content, accuracy, and study validity in Validation Deliverables.
• Identification and Implementation of process changes to streamline current practices.
• Identification and Implementation of process changes to deliver Cost effective measures / Lean Concepts.
• Drives process improvement initiatives and develops guidance on best practices when required.
• Ensures staff compliance to policies and regulatory guidelines through completed trainings, assigned readings or other modes.
• Informs Management of any staff, procedural or site problems that may affect integrity of the data; has ownership in corrective action of problems independently.
• Performs leadership activities for staff recruitment, onboarding, retention, performance evaluation, improvement and/or disciplinary.
• Developed as an internal expert in a key process/area for the department.

Requirements:

• Bachelor’s degree in science / engineering or related field + 5 years of relevant work experience
• OR master’s degree + 3 years of relevant work experience
• Previous supervisory and people management experience.
• Knowledge of appropriate regulatory agency requirements / guidelines. E.g. EU GMP’s / FDA , Data Integrity, etc
• Previous Experience related to full responsibility for a site, or projects, full validation requirements
• Experience working in all aspects of a Quality Management System