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Lead Quality Assurance Specialist
1 month ago
Pharmascience seeks an experienced Lead Quality Assurance Specialist to join its operational team. This challenging role requires a skilled professional who can maintain high quality standards at the operational level by ensuring the adequate application of Good Manufacturing Practices and internal procedures.
The successful candidate will be responsible for monitoring KPIs measuring the health of quality systems, such as CAPAs and deviations. He/she will actively participate in multi-functional teams addressing quality incidents, establish scope, impact, immediate corrective action, and investigation criticality.
The Lead Quality Assurance Specialist will conduct review and approval of minor and major deviation reports and INF/FOR/WI. He/she will interface with all other operational departments in matters of Quality, contributing to establishing and maintaining the culture of quality throughout Pharmascience's operational structure.
This role involves:
- Performing internal audits of the production floor and reception/sampling activities;
- Verifying the application of GMPs, Health & Safety, and internal procedures, making recommendations, and managing cases of non-conformity;
- In cases of non-conformity, participating in the determination of immediate action requirements, including lot or partial lot inspections, and lot disposition; coordinating/performing inspections;
- Documenting actions and lot disposition information electronically in Trackwise and SAP;
- Actively participating in discussions and facilitating engagement by cross-functional teams; representing Quality in SWAT discussions and ensuring correct actions are performed from a quality and compliance point of view;
- Supporting investigators of non-conformances and implementing effective CAPAs as required; categorizing quality events and ensuring immediate actions are identified/adequate and performed;
- Supporting audits (client, regulatory, internal) as required;
- Maintaining Operational Quality Advisor team tools and files;
The ideal candidate should possess:
- Capacity to take decisions and communicate them with tact and diplomacy;
- Strong problem-solving skills;
- Proven coaching and leadership skills;
- Analytical skills;
- Thoroughness and rigor;
- Observation skills;
- Solid organizational skills;
- Technical writing skills;
- Proficiency in French and English (oral and written);
- Competence with MS Office, SAP.
Estimated salary range: $80,000 - $120,000 per year, depending on experience and qualifications. Please note that this is an estimate based on industry standards and may vary based on individual circumstances.
