We are currently seeking a senior specialist to oversee all validation activities, ensuring compliance with current regulatory requirements and company standards. This is a critical role for any professional looking to join a leading organization that sets the standard in their industry.
This position is responsible for managing the qualification/validation of facilities, utilities, equipment, computer systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units, and shipping processes. A key aspect of this role is providing quality oversight to commissioning, qualification, and validation activities associated with facility start-up projects and supporting the transition from project phase through sustaining phase.
* Ensure the quality oversight of qualification/validation activities for all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units, and shipping processes.
* Review and approve validation documentation and associated data, including but not limited to plans, URSs, quality risk assessments, protocols, and reports, to ensure conformance to SOPs, specifications, and other applicable acceptance criteria.
* Provide QA oversight to events/deviations, investigations, and change evaluations occurring during qualification/validation activities and ensure adherence to SOPs and cGMP requirements.
* Review and maintain up-to-date knowledge of cGMP regulations and guidance related to all aspects of validation and/or qualification.
* Coordinate QA validations activities to ensure schedule adherence and on-time delivery of project deliverables.
* Manage and develop the QA validations team, including performance management, recruitment, and training.
* Other quality-related tasks as assigned.
Required Skills and Qualifications
* Bachelor's degree in a scientific or engineering discipline (e.g., biochemistry, chemistry, engineering).
* At least 3 years of experience in a Quality Engineering/Quality Assurance/Quality Validations role in a regulated environment.
* Thorough understanding of validation requirements for cGMP manufacturing facilities.
* Strong technical skills and problem-solving abilities.
* Deep knowledge of GxP regulations and industry standards applicable to validation, including GAMP, ISPE, ISO, ASME, and BPE.
Benefits
As a senior specialist, you will have the opportunity to work with a leading organization and contribute to the development of quality standards in your industry. You will also have the chance to develop your skills and expertise in a dynamic and challenging environment.
Additionally, you will have access to ongoing training and development opportunities, as well as the support of a collaborative and experienced team.
Others
If you are a motivated and detail-oriented individual with a passion for quality and excellence, we encourage you to apply for this exciting opportunity.