Responsibilities and Duties:
QA Batch release/ process validation coordinator
- Review Batch records and issue batch records on daily basis.
- Maintain company Validation system by validating current production processes.
- Coordinate with production department to follow up with the validation activities and coordinate the process validation and cleaning validation.
- Write and update process validation/qualification protocols and reports. Prepare allergen statements and BSE/BE.
- Check reports, records and data for completeness and accuracy as well as to confirm their compliance with internal procedures and US FDA and Health Canada regulations.
- Help sales department preparing document requested by foreign authority.
- Regularly update the QA Manager on project status, issues, and progress.
- Performs other duties as requested by Quality management.
- Coordinate Process Validation/ cleaning validation sampling.
Preferred Qualifications and/or Experiences:
- University education in biology, biochemistry, chemistry, engineering, or pharmaceutical science.
- Good communication skills and a familiarity with electronic software (e.g. Word and Excel).
- Previous industry experience in a pharmaceutical/nutraceutical manufacturer would be considered an asset.
- Good working knowledge of Canadian GMP quality systems/regulations would be considered an asset.
- Ability to fluently speak, write, and read in English and Chinese would be considered an asset.
Job Types: Full-time, Permanent 8:30 - 17:00 Monday to Friday
Salary: $40,000.00-$50,000.00 per year
For interested parties, please send your application with CV to hr@vivapharm.com.