About the company This organisation is a leading global pharmaceutical company with local manufacturing.About the opportunity In your role, you will join a team responsible for the establishment and execution of the validation project strategy for a given sector of validation (i.e.
equipment, computer system validation, continued process verification, process, cleaning, etc.)
to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies.
More broadly, you will be joining a department that aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.ResponsibilitiesManage multiple projects according to the CPA agreed timings and outcomes.Organize, lead, and facilitate effective meetings.
Identify and delegate action items.
Facilitate action items to completion.
Identify and resolve project issues.Lead a team of Validation Engineers/Associates.
Mentor and provide leadership and development opportunities to the team.Provide technical leadership regarding the development of validation strategies and validation master plans post projects.Contribute to the generation of user requirements for equipment, facilities, and services.Ensure that appropriate systems are in place such that site operations meet or exceed the requirements.Develop validation strategies, validation master plans, and documentation for facilities, utilities, manufacturing equipment, packing lines, laboratory equipment, and computer systems.Integrate qualification activities into Pfizer quality management systems.Develop necessary programs to understand and document Critical Quality Attributes for products, Critical Process Parameters for processes, and Critical Attributes for equipment.Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines.Prepare and execute the site internal audit program including completion of identified actions.Support the regulatory audit program.Develop, introduce, and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards.Skills and ExperienceBachelor's Degree and several years of experience in a similar role.People leadership experience.Extensive experience dealing with regulatory and third-party representatives.Good organizational, presentation, meeting facilitation, project/time management, and technical writing skills.Master's degree and relevant pharmaceutical experience.Extensive understanding and knowledge of regulatory requirements and validation as applied to pharmaceutical equipment and facilities.Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies.Strong analytical and problem-solving abilities.How to Apply Click apply or contact Jo Turner ) or Rohan Lallbeeharry ) for a confidential discussion.
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