Quality/regulatory Affairs Coordinator- Woodbridge
1 week ago
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.**Bringing out the best in people**- Working at Dentsply Sirona you are able to:
**Develop faster** - with our commitment to the best professional development.**Perform better** - as part of a high-performance, empowering culture.**Shape an industry** - with a market leader that continues to drive innovation.**Make a difference** -by helping improve oral health worldwide.**Summary of Position**:
- The RA/QA Associate aids with the general maintenance of the internal Quality System as per Health Canada requirements.
- Develops and implements the internal Quality System through current Health Canada requirements and approved RA/QA processes.
- Collaborates with other functional departments within Dentsply Sirona Canada.
- Works together with inter-divisional and Dentsply Sirona Canada Suppliers.
- Organizes all RA/QA activities to ensure that all Health Canada and Corporate requirements are well maintained and followed by other functional areas.
- Coordinates other administrative work which includes record retention of documents related to all RA/QA function.
**Main Accountabilities**
- Internal Quality System: ongoing monitoring to ensure its compliance with applicable regulations
- Maintains internal change control system.
- Acts as a back-up contact prior to, during, and after any regulatory agency inspections.
- Coordinates corrective action process for all aspects of the divisional CAPA (Corrective and Preventative Action).
- Maintains all documents related to the distribution of Pharmaceutical and Natural Health Products as required by Health Canada and GMP guidelines.
- Inspects product test results and all documents related to Pharmaceutical and Natural Health Products to ensure its compliance with Health Canada requirements.
- Ensures product specification compliance with current Health Canada Regulations (example: artwork, product packaging, package insert slip, DIN/NPN numbers).
- Requests and reviews Certificate of Analysis/Batch Certificate for the received products from manufacturer.
- Confirms appropriate transportation temperature range by reviewing temperature monitors for Pharmaceutical/ Natural Health Product shipments; initiate corrective actions for all non-conformance notifications.
- Monitors Health Canada requirements to ensure on-going compliance.
- Assist with Quality System /GMP training to comply with Health Canada requirements
- Maintains training metrics to ensure that Health Canada requirements are followed with discipline.
- Assists with the planning of all internal GMP training.
- Publishes updated list of training effectiveness results.
- Assists with the coordination of new hire training. Work with RA/QA Coordinator or consultants to obtain and deliver proper training.
- Assist in coordination of prompt and efficient handling of product recalls, complaint handling and Pharmacovigilance complaint processes and/or any other RA/QA related issues.
- Acts as the Divisional Compliance Officer (DCO) to ensure that all Corporate/ Health Canada requirements are met.
- Effectively communicates with internal and external contacts (Customer Service Department, Customers, and inter-divisions) to obtain all necessary information pertaining to reportable events.
- Coordinates the submission of all reportable Pharmaceutical and Medical Device complaints (both foreign and Canadian) to Health Canada according to the time frame set out by Canadian regulations.
- Coordinates the preparation and execution of recalls to Health Canada in the timeframe set by Health Canada.
**Education/Experience/Qualifications**
- 1-3 years regulatory/quality assurance experience in Pharmaceutical or Medical Device industries.
- Bachelor’s Degree in Science or related technical field.
- Ability to work well within a team environment.
- Results oriented and highly self-motivated.
- Able to strike a proper balance between catalyst for change and team player.
- Sound risk management and decision-making skills.
- Critical and analytical problem-solving skills.
- Strong ability to multi-task and juggle various projects effectively.
- Adaptability to changing demands and conditions.
- Excellent organizational and time management skills.
- Strong interpersonal skills.
- Strong written
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