As a Validation and Compliance Specialist, you will play a key role in ensuring the on-going validation and compliance of existing and new equipment, systems, and processes.
Responsibilities:
* Designing, executing, and reporting on Process Performance Qualifications
* Ensuring validation studies are managed in accordance with all relevant standards and regulations
* Providing technical interpretation and guidance of current regulatory requirements
* Maintaining validation documentation throughout the validation lifecycle
* Participating in external regulatory inspections
You will also be responsible for ensuring that the validation status of equipment and systems is compliant with cGMP at all times. Additionally, you will maintain validation documentation throughout the validation lifecycle and participate in external regulatory inspections.
Requirements:
* Ability to troubleshoot validation issues associated with projects and process development
* Competent knowledge of pharmaceutical manufacturing processes
* Previous validation/product development experience is highly desirable
* Knowledge of Process Validation regulations and industry practices
* Full understanding of relevant quality and compliance regulations
Able to execute projects efficiently and possess good knowledge of quality management systems. Good communication skills at organisational, team, and individual levels are also essential. Ability to use project management tools such as MS Project is an advantage.
This is a challenging yet rewarding role that requires a strong attention to detail and ability to work independently. The successful candidate will have a proven track record of delivering high-quality results in a fast-paced environment.