Validation Specialist
We are seeking a highly motivated Validation Specialist to join our team in a role that will be instrumental in forging the company's validation processes.
Key Responsibilities:
* Develop and execute validation projects for existing products and new product introductions.
* Participate in project teams to determine project schedules and validate project milestones.
* Collaborate with cross-functional teams to identify and mitigate risks associated with validation activities.
* Investigate, track and resolve deviations during qualification activities.
* Support departmental objectives and undertake assigned projects while fostering positive working relationships.
* Maintain validation status through regular reports and meetings, collaborating with project managers to adhere to schedules.
* Ensure compliance with Good Manufacturing Practices (GMP) and stay up-to-date on validation innovations.
* Generate and execute validation protocols, review project change controls, and prepare necessary documentation and reports.
* Contribute to developing company validation standards and assist with department growth as needed.
* Present professionally to management and auditors, supporting processes and addressing queries during regulatory inspections.
* Liaise with quality assurance personnel to complete project documentation within defined time frames.
This role requires strong organizational and communication skills, with the ability to work independently and collaboratively within a team environment.
The ideal candidate will have a background in validation, with experience in generating, executing and closing out validation projects. A strong understanding of GMP and validation regulations is also essential.