Job Summary:
The Validation and Qualification Specialist plays a crucial role in supporting new product introductions, equipment qualification, and site requalification programs.
* Design and execute PV/Process Performance Qualifications
* Plan and conduct validation studies for equipment, systems, and processes
* Manage validation documentation in accordance with regulatory requirements (Health & Safety, cGMP)
* Provide guidance on US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation
* Maintain comprehensive validation records throughout the lifecycle
* Participate in external regulatory inspections to ensure compliance
* Support Site Change Control processes to maintain operational efficiency
Key Responsibilities:
* Troubleshoot validation issues related to projects and process development
* Technical knowledge of pharmaceutical manufacturing operations
* Experience in validation/product development is advantageous
* Familiarity with Process Validation regulations and industry best practices
* Understanding of GAMP, ISPE guides, and validation publications such as AAMI/ANSI, PDA, ISO
* Knowledge of quality and compliance regulations
* Ability to execute projects according to plan
* Good understanding of quality management systems
* Strong communication and interpersonal skills
* Experience with MS Project and SPC packages is a plus
* Understanding of site KPIs
Requirements:
We are seeking a highly skilled and detail-oriented individual who can:
* Evaluate and implement effective solutions to validation challenges
* Develop and maintain strong relationships with cross-functional teams
* Communicate complex information effectively to both technical and non-technical stakeholders
* Stay up-to-date with changing regulatory requirements and industry trends