This position is responsible for ensuring compliance with applicable regulations (i.e. Cosmetics Regulations, Food and Drugs Act and Regulations, Natural Health Products Regulations, FDA, EMA, etc.), 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, qualification and calibration reports).
- Review and release of laboratory results.
- Review out-of-specification, out-of-trend and other investigations
- Providing support with maintaining Quality System, including drafting and updating quality procedures.
- Perform technical writing tasks such as Method Validation Protocols
- Assisting with internal and external audits.
- Ensuring that all reports and accompanying raw data are according to GMP, 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 GMP documents for the evaluation of complaints.
- Perform and manage the internal auditing program if required.
- Manage the ongoing tracking and maintenance of GMP documents
- Develop, review and revise training materials. Assist in training of new staff.
- Evaluate and summarize instrumentation data in final reports.
- General record-keeping practices according to local and global SOPs including maintenance of on- and off-site archive.
- Assist in issuing logbooks and forms when needed.
- Review training records and generate associated reports if required.
- Initiate and investigate deviations if required.
- Perform risk assessment pertaining to discovered deviations.
- Initiate and conduct Corrective Action and Preventative Action (CAPA) plans.
- Initiate and assist in Change Control procedures.
- Assist in and perform trending and prepare reports as per relevant procedures.
- Adhere to the Standard Operating Procedures.
- Circulate Standard Operating Procedures and follow up on training requirements.
- Ensure that all staff members are always following the Standard Operating Procedures.
- Assist with the maintenance of Health Canada and FDA accreditation.
- Assist in summarizing information and report preparation for Management Review.
- Attend staff meetings.
- Any other duties as delegated by the Quality Assurance Manager or designate.