Pharmaceutical Validation Expertise
This role offers an exciting opportunity to contribute to the validation program, ensuring the maintained validated state of facilities, utilities, equipment, IT infrastructure, devices and compounding processes.
* Coordinate activities of assigned personnel to ensure quality of completed work.
* Manage development, implementation, and execution of validation protocols and procedures.
* Interface with suppliers/vendors to address documentation and compliance issues.
* Prepare documentation for regulatory submissions/audits and present validations during inspections.
* Execute validation protocols and prepare reports.
* Maintain the validated state through proper change management.
* Ensure filing and documentation are up-to-date and compliant with standard processes.
Requirements:
* Bachelor's Degree in a scientific or related field.
* Five years' experience in a similar position is essential.
* Experience in developing, executing, monitoring, and managing validation activities.
* Process validation experience is highly regarded.
* Demonstrated knowledge of qualification and validation requirements within the pharmaceutical industry.
* Proven time management skills.
* Ability to solve problems effectively and independently.
* Excellent communication and report writing skills.