Quality Assurance
2 weeks ago
**Quality Assurance & Regulatory Affairs Specialist position**
HANSAmed is a specialty Cell-Tissue-Organs, Medical Device, and pharmaceutical distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed represents leading brands in their respective category.
Hansamed Ltd /Citagenix is importer and distributor of Drugs, Medical Devices (MD), Cell-Tissue-Organs (CTO) and Natural Health Products (NHP) in Canada. Also, Hansamed Ltd /Citagenix is importer and distributor of Medical Devices (MD), and Cell-Tissue-Organs (CTO) in USA. Furthermore, Hansamed Ltd is owner of Health Canada licenses for drug, and MD. Quality Assurance and Regulatory Affairs (QA & RA) department is a fast-paced environment. QA & RA specialist position is a GMP role responsible for a wide variety of Quality Assurance and Regulatory Affairs activities related to Drugs, MDs, CTOs and NHPs. In addition, QA & RA specialist will communicate with vendors, review documentation and processes, contribute to Drugs or MD submissions, and maintain all documentation and records. Main responsibilities are below.
**Compensation**:70K - 90K
Essential Job Functions
General
- Support and maintain a process that ensures all requirements from Health Canada and FDA are met
- Maintain all documentation and necessary records for Drugs, MDs, CTOs and NHPs activity
Quality Assurance
- Review and update of SOPs and standard forms; write new SOPs
- Participate in Health Canada GMP inspection
- Main support on maintaining Quality Management Systems (QMS) for Drugs, MDs, CTOs
- Documentation review and drug inspection for batch release, including narcotics
- Full process for Quality Product Complaints for Drugs, MDs, CTOs, NHPs
- Documentation of Change controls and Deviations
- Review and maintain all documentation from DIN manufacturers including Quality Agreements, Product Quality Reviews, Stability data /reports, Master Batch Records, etc
- Participate in annual self-inspection and corrective /preventive actions
- Review of all returned products
- Participate in Health Canada, and FDA inspections for MDs, and CTOs
- Review of imported NHP finished products
- Review and documentation of Emergency Kits
- Support on ISO-13485 certification and recertification for MD Quality Management System
- Support business activities with all suppliers
- Preparation, review and maintenance of any logs, spreadsheet, or records
- Support with GMP and QMS training of staff
- Other responsibilities as related to Quality Assurance activities
Regulatory Affairs
- Support submission process for existing and new products, drugs, MDs, NHPs
- Review and document all ADRs, and forward to the respective authorities, when needed
- Support and records on Drug PharmacoVigilance process, and MD Problem Reporting
- Support on renewing all drug and MD licenses, and updating all licenses: DEL, MDEL, CTO, NHP SL
- Participate to comply with Recall procedure for drugs, MDs in Canada, and MDs and CTOs in USA
- Participate in Health Canada Pharmacovigilance inspection
- Support or prepare any regulatory change submission for drugs in eCTD format /software, including manufacturing process cooperating with drug manufacturer
- Support and review final submission documents, keep submission copy and e-file
- Other responsibilities as related to Regulatory Affairs activities
**Requirements**:
- University degree in physical science (chemistry, biology, etc), or life science (pharmaceuticals, pharmacy, etc), or equivalent
- Knowledgeable, thru education and /or professional experience in QA systems and /or Regulatory Affairs for Drugs and Medical Devices
- Several years of experience in pharmaceutical companies preferred
- Knowledgeable in Health Canada requirements for Quality Management Systems for Drugs activities
- Knowledgeable in FDA requirements for Quality Management Systems for MDs and CTOs is an asset
- Knowledgeable, thru education and /or professional experience in Drugs Pharmacovigilance and MDs Problem Reporting
- Knowledge and experience in Health Canada requirements for NHPs activities preferred
- Excellent writing and communication skills in English
- Very good computer knowledge, MS office (Word, Excel), Adobe, Network environment
- Knowledge of a QMS software (like Qualio, TrackWise, or equivalent) is an asset
- Strong Self-management skills and Organizational skills
- Clear Communication skills
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Mississauga, ON L5N 8G4: reliably commute or plan to relocate before starting work (preferred)
**Salary**: $70,000.00-$90,000.00 per year
**Benefits**:
- Dental care
- Paid time off
- Vision care
Schedule:
- 8 hour shift
- Day shift
Ability to commute/relocate:
- Mississauga, ON L5N 8G4: reliably commute or plan to relocate before starting w
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