Job Summary:
Responsible for providing quality and technical support for quality and validation activities related to manufacturing equipment, processes, and utilities.
Job Responsibilities:
- Oversight of qualification and validation related activities to the manufacturing facility and quality control laboratories
- Qualification and assessment of utility equipment and instrumentation
- Involvement in investigations of deviations related
- Review equipment/instrument validation, qualification, re qualification protocols including IQ, OQ, PQ
- Assist with internal and external audits
Job Qualifications:
- Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment
- Preferably knowledge of Trackwise
- Must be flexible in terms of working hours to meet requirements of position
- Sound knowledge of pharmaceutical quality system requirements
- Skills to independently evaluate situations and propose potential solutions are essential
