Job Overview
The position of QMS/Document Coordinator includes, but is not limited to, coordinating QA related issues, maintaining and updating records, providing administrative support and assisting in ensuring corporate compliance with GMP regulations as required by Health Canada, the US FDA, and Viva Pharmaceutical Inc.'s other contractual Obligations.
Responsibilities
- To work cooperatively with others for compliance with GMP regulations as required by Health Canada, The US FDA, or other Jurisdictions, in order to maintain GMP Status.
- As required, participate in internal GMP and third party audits.
- Coordinate with QC, QA, Production and HR on documents related issues.
- Preparing Training flow charts, Power Point Slides and Quizzes to implement trainings.
- SOP and SSD creation, editing, and follow up approval.
- Investigate, prepare a report on Customer complaints and respond in a timely manner.
- As required, participate in examining the results, change controls requests when necessary, generate deviation reports, Investigate root cause determination, and provide recommendation for corrective actions/ CAPA.
- Review Certificate of analysis, Calibration reports, Batch manufacturing records, Batch Packaging records, and packaging SOI for any discrepancies, or errors, deviations and investigations (etc.) that could or may have the potential to affect the efficacy of the batch.
- As required, contact customers and internal departments to respond to their inquiries and resolve QA issues.
- Ensure to perform Risk Assessment using FMEA in every stage throughout the process when required.
- Review master manufacturing records and change controls for any changes in the ingredients, processing steps and equipment.
- Review of SOPs, Bill of materials, customer signed PFSS documents and manage them in the ERP system.
- Prepare a report of Annual Product Review as per the clients request and respond to clients in a timely manner.
- Ensure all employees carry out Good Manufacturing Practices (GMP).
- Involve in the management of Waste disposals of Raw materials and Packaging materials.
- Coordinate with other RA employees to file the excise duty of alcohol.
- Act as alternate person to issue Allergen statements to Finished Products and Raw Materials.
- Issuing of GMP certificate to customers as per the sales department's request.
- Participating in other tasks that are assigned by the management.
Skills
- Good understanding of GMP requirements, Documentation practices
- Knowledge of data integrity principles, master document control, Change controls and CAPA systems
- Experience in handling Customer complaints, Deviations / non-conformances / OOS, CAPA investigations, QMS documentation
- Experience with BOM (Bill of Materials) review, formula verification and revision, Label review and approval process
- Familiarity with ERP/QMS systems, Audit trail awareness, Product release documentation and Specifications
- Preferred Knowledge of Health Canada GMP requirements, U.S. Food and Drug Administration GMP requirements, NHP and dietary supplement regulations.
Job Types: Full-time, Permanent
Pay: From $48,000.00 per year
Work Location: In person
