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Corporate Quality Systems Specialist-QAA
2 months ago
The Corporate Quality Systems Specialist-QAA will play a critical role in the maintenance and improvement of the Quality Agreements process. The incumbent will be responsible for supporting the creation of change control, deviations, CAPA, etc when applicable.
Key Responsibilities- Process owner of the Quality agreement process.
- Develop and review quality agreements: Collaborate with internal stakeholders and external partners to develop and review quality agreements that outline the quality requirements, responsibilities, and expectations for both parties.
- Assess current quality agreement processes and systems: Evaluate the existing quality agreement processes and systems to identify areas for modernization and improvement. Determine how technology solutions can be leveraged to streamline processes, enhance efficiency, and improve the process for delivering quality agreements.
- Collaborate with cross-functional teams to develop strategies for modernizing the quality agreement system and process. Identify and prioritize areas for improvement, develop implementation plans, and oversee the execution of modernization initiatives specifically targeted for quality agreements.
- Ensure compliance: Ensure that the quality agreements align with regulatory requirements, industry standards, and company policies. Continuously monitor and assess adherence to the agreed-upon quality standards.
- Evaluate supplier's compliance: Evaluate the quality performance of suppliers through the vendor management evaluation process for the identified suppliers.
- Support contract negotiations: Collaborate with legal and business teams to provide quality assurance expertise during contract negotiations, ensuring that quality requirements are adequately addressed in the agreements.
- Act as the primary point of contact for Quality Agreement creation/modification.
- Provide quality guidance: Act as a subject matter expert on quality assurance matters related to quality agreements. Provide guidance and support to internal stakeholders and external partners to ensure compliance with quality requirements and required audit requests.
- Organize and coordinate meetings with suppliers. Communicate with internal/external stakeholders to resolve QAA issues.
- Perform QAA quarterly reviews to assess the status of the QAA process.
- Create and maintain comprehensive dashboard, compile KPI data, perform trends analysis and create applicable reports related to QAA.
- Provide data to Managers and Directors for preparation of monthly/quarterly Quality Systems reports including quality issues, metrics, and summary of any quality problems.
- Initiate Change Control, Deviation, and Corrective Action and Preventive Action (CAPA), when applicable.
- Assist in the risk assessment process.
- Participate in the GMP annual training.
- Participate in the creation and revision of Standard Operating Procedures (SOPs) and Working Instructions (WIs).
- Participate in the preparation for Health Canada and Corporate inspections along with the creation of corrective action and preventive action plans.
- Ensure GMP training compliance.
- Support or lead special projects and assignments as needed.
- Remain current on regulatory and technical changes within the industry.
- Bachelor of Sciences in Chemistry, Biology, or in a related field.
- 5 years of work experience in the pharmaceutical industry in Quality Assurance.
- Strong knowledge of Health Canada's GMP Regulations including those applied to Drugs, Medical Devices, Food products along with wholesalers and distributors/importers.
- Documentation management, Quality system, QAA management.
- Experience with electronic Quality Management System in an established QA function within pharmaceutical/healthcare industries.
- Knowledge of Microsoft Suite: Outlook, Word, Excel, and PowerPoint, ERP.
- Bilingual (spoken/written English and French).
- Excellent organizational and time management skills with the ability to manage several projects at once.
- Meticulous and detail-oriented.
- Strong analytical skills, excellent interpersonal and written & oral communication skills.
- Proactive and strong team player.
- Ability to work independently and make decisions based on judgment and integrity.
- Works well under pressure.
- Familiarity with quality management systems and tools.
- Certification in quality assurance or related field (e.g., Certified Quality Auditor) may be beneficial.
