Equipment Validation Specialist
The QC Department is responsible for the qualification/validation of laboratory equipment, systems and processes. The role of the Equipment Validation Specialist is to ensure customer satisfaction with each validation, revalidation and project work.
This specialist will oversee, coordinate, guide and implement site validation master plans under prospective, concurrent and retrospective validation studies in a timely manner.
Responsibilities:
1. To actively work on validation projects being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations.
2. Participate in risk assessment process and design review process.
3. Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire)
4. Facilitate PQR review process/regulatory review process and laboratory equipment review process as per current rota's.
5. Keep abreast of current and changing regulatory guidance for relevant areas of validation that applies.
6. Provide support for audit preparation, direct audit interaction and involvement in audit response.
7. Support internal EHS requirements, procedures and policies and ensure continued conformance to EMS within the department.
8. Qualifications:
* Bachelor's degree required in science based or engineering discipline.
* Experience in Pharmaceutical company.
* Excellent project management skills.
* Proficient in use of Microsoft Office suite of programs.
* Critical thinking and problem-solving skills.
* Ability to articulate clearly when dealing with internal and external bodies.
* Excellent conflict handling skills.