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 which is 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 which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team. 


Responsibilities

• Manage 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.  Identifying and resolve project issues. 
• Lead a team of Validation Engineers/Associates.  Mentor and provide leadership and development opportunities to team.
• Provide technical leadership regarding the development of validation strategies and validation master plans post projects
• Contribute to 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 of validation strategies, validation master plans and documentation for facilities, utilities and manufacturing equipment, packing lines, laboratory equipment and computer systems. 
• Integrate qualification activities to 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 site internal audit program including completion of identified actions.
• Support 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 Experience

• Bachelor’s Degree and several years’ experience in a similar role   
• People leadership experience. 
• Extensive experience talking/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 the 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 (03 9938 7120) or Rohan Lallbeeharry  (03 9938 7100) for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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