Description
Responsibilities:- Ensure management responsibility
- Ensure human resource are properly placed and trained
- Ensure facility and equipment are properly placed, maintained, calibrated and validated
- Ensure product is developed per design control requirement and changes are controlled
- Monitor supplier performance regularly
- Ensure product process is validated and followed, deviation is controlled
- Participate in risk assessments.
- Participate in the audit response process.
- Ensure incoming, in process, and final process inspection are controlled, deviation and non-confirming product or process is controlled
- Ensure continual improvement, corrective and preventive action are in placed.
Qualifications
BASIC QUALIFICATONS:
- Bachelor's degree in Science and a minimum of 3 years of experience working in a regulated, GMP environment or Master's degree and a minimum of 2 years' experience, or PhD degree
- Demonstrate knowledge of cGMP / ISO 13485 / ISO 9001 regulations and guidance.
- Excellent communication, organizational skills, multitasks, management skill, analytic skill, computer skill, close attention to detail.
PREFERED QUALIFICATIONS:
- Ability to effectively collaborate and communicate with other areas, such as third-party
- Remediation group to drive towards continuous quality operational excellence.
- Experience in training individuals on process knowledge.
- Demonstrated leadership.
- Operations experience in one of the following areas: Quality Assurance, Quality Control,
- Manufacturing Technical Support, Facilities Engineering, or Automation.
- Work with training to develop technical training modules and tools for training QA on the
- technical aspects of the process and batch records
- Work with cross-functional teams to drive towards continuous quality operational excellence
- Familiar with Filemaker is a plus
To find out more about Real please visit www.realstaffing.com