Quality Assurance & Regulatory Affairs Associate position – Pharmaceuticals & Medical Devices

Mississauga, ON

Quality Assurance & Regulatory Affairs Associate position –

Pharmaceuticals & Medical Devices

HANSAmed is a specialty Medical Device, Cell-Tissue-Organs, and pharmaceutical importer and 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 categories.

Hansamed Ltd /Citagenix is importer and distributor of Drugs including Narcotics, Prescription, ethical and OTC 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 Human-Cell-Tissue products (HCTP) in USA. Furthermore, Hansamed Ltd is owner of Health Canada drug license for dental anesthetics. QA & RA associate 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 associate will communicate with vendors, prepare documentation and processes, contribute to Drugs or MD submissions, and maintain all documentation and records. Detailed responsibilities are below.

Compensation: 60K to 70K

Location:         Mississauga, ON.

Essential Job Functions and Responsibilities

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
• Ability to adapt and maintain attention to detail while working in a dynamic, fast-paced environment

Quality Assurance

• As approved AQPIC, perform all the duties related to Narcotics activity onsite (e.g. Product receiving, inspection, distribution, monthly reporting etc.)
• Maintain the Quality Management Systems (QMS) for Drugs, MDs, CTOs /HCTPs
• Write new SOPs. Review and update of SOPs and standard forms.
• Documentation review and drug inspection for batch release, including narcotics
• Full process for Quality Product Complaints for Drugs, MDs, CTOs, NHPs
• Review and documentation of all returned products
• Review and documentation of starting materials, and Emergency Kits
• Review of imported NHP finished products
• Participate in Health Canada GMP inspection
• Participate in Health Canada, and FDA inspections for MDs, and CTOs /HCTPs
• Participate in annual self-inspection and corrective /preventive actions
• Support on ISO-13485 certification and recertification for MD Quality Management System
• Documentation of Change controls and Deviations
• Prepare, review and maintain all documentation from DIN manufacturers
• Preparation, review and maintenance of any logs, spreadsheet, or records
• Support with staff GMP and QMS training
• Perform quality inspection of facilities
• Other responsibilities as related to Quality Assurance activities

Regulatory Affairs

• Review and document all ADRs, and forward to 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, wholesale/ distributor, tissue bank, FDA registrations
• Participate to comply with Recall procedure for drugs, MDs in Canada, and MDs and HCTPs in USA
• Participate in Health Canada PharmacoVigilance inspection
• Support submission process for existing and new products, drugs, MDs, NHPs
• Support any regulatory change submission for drugs in eCTD format /software
• Support and review final submission documents, keep submission copy and e-file
• Support international regulatory documentation requests
• Maintain, submit monthly narcotics report to Health Canada
• Other responsibilities as related to Regulatory Affairs activities

Requirements

Pre-Requisite for this position:

Bachelor’s degree in science or a related field (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Kinesiology, Pharmacology, Pharmacy, Biomedical Sciences, etc.) 

4+ years of experience in pharmaceuticals and/or Medical Devices (MD) in an associate or above role; meet all Health Canada requirements to be approved as AQPIC (Narcotics activity); skilled on writing GMP technical documents; proven experience on regulatory of drugs and MDs; strong knowledge of Health Canada (HC) Drug regulations, as well as HC and US FDA MD regulations.

Do not apply if you do not meet these minimum requirements.

Note: Specialized degree in Quality Assurance/ Regulatory Affairs and/ or Regulatory Affairs Certification (RAC) is considered an asset

• Strong knowledge, thru education and /or professional experience in QA systems and /or Regulatory Affairs for Drugs and Medical Devices
• 4+ years of experience in pharmaceutical and/or MD companies
• Ability to be present on-site for a minimum of 4 days/ week
• Strong knowledge of Health Canada requirements for Good Manufacturing Practices (GMP) for Drugs
• Strong knowledge of Health Canada requirements for Quality Management Systems (QMS) for MDs
• Experience in narcotics handling (e.g., AQPIC) is an asset
• Knowledgeable in FDA requirements for Quality Management Systems for MDs and HCTPs
• Experience in preparation of drug submission is an asset
• Knowledgeable, thru education and /or professional experience in Drugs Pharmacovigilance and MDs Problem Reporting
• SAP experience is an asset
• 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
• Strong Self-management skills and Organizational skills
• Strong problem-solving skills

What's in it for you

• Salary range $60,000 to $70,000 depending on experience
• Bonuses $1,500 to $2,000 annually based on performance
• Full benefits
• RRSP plan
• 15 PTO days to start