This position is responsible for ensuring compliance with applicable regulations (i.e. ISO 17025, GMP, GLP), for clients requiring quality assurance services.
Responsibilities:
- Review and determine the status of the quality documents (including, but not limited to, raw laboratory data, validation studies, logbooks, and calibration reports)
- Providing support with maintaining Quality System, including drafting and updating quality procedures
- Assisting with internal and external audits
- Ensuring that all reports and accompanying raw data are according to GMP and ISO 17025, accurate, correct and acceptable according to the study protocol, methods and relevant SOPs
- Interacting with department staff to acquire information for report writing and auditing purposes and present information to staff regarding deficiencies and areas of improvement
- Log and review complaints; compile required ISO 17025/ GMP documents for the evaluation of complaints
- Perform and manage the internal auditing program if required
- Manage the ongoing tracking and maintenance of GMP and ISO 17025 documents
- Support the training of new staff
- Evaluate and summarize instrumentation data in final reports
- General record-keeping practices according to local and global SOPs
- Review training records and generate associated reports if required
- Initiate and conduct deviations and out-of-specification investigations
- Initiate and conduct Corrective Action and Preventative Action (CAPA) investigations
- Initiate and assist in Change Control procedures
- Adhere to the Standard Operating Procedures
- Circulate Standard Operating Procedures and follow up on training requirements
- Ensure that all staff members are following the Standard Operating Procedures at all times
- Assist with the maintenance of ISO 17025 and GMP accreditation
- Attend staff meetings
- Any other duties as delegated by the Department Head or designated