Quality Assurance Manager

Benefits

• Dental insurance
• Health insurance

The Quality Assurance Manager has process-oriented responsibility and oversight for the Quality Management System focused on compliance to applicable regulations including but not limited to FDA and Health Canada for OTC, NHP and Cosmetic products. Direct responsibility for QMS, batch release, deviation, resolution, correction and prevention; with focus on continuous improvement, right the first time and on time delivery.

• Batch Release: Manages approvals for raw materials and finished product release, rejection and quarantine.
• First Time Quality: Actively monitors production lines and product launches to ensure first time quality is achieved by supervising the IPQA team for conformity to prescribed standards based on audit samples pulled from the Production Lines; generate compliance and non-compliance/variance reports inclusive of root cause analysis, risk analysis based on aspects introduced to the manufacturing process, and recommendations for corrective actions.
• Leads, co-ordinates and supports activities associated with plant hygiene, site microbial risk profile through in-process checks and risk impact assessment.
• Ensure site compliance with both Apollo policies, quality/technical standards, health, safety, and environmental regulations, and regulatory requirements (Health Canada, FDA).
• Supports the Quality Laboratory & manufacturing plant with a broad base of experience and expertise in process hygiene, personal hygiene, and material hygiene.
• Oversees concer B vice control: change controls, test procedures, local SOPs and protocols and reports.
• Performs regular GEMBA walks and housekeeping inspections in the manufacturing areas and labs.
• Assist with investigations into microbiological failures/non-conformances and coordinate CAPA activities to mitigate microbiological risks as needed.
• Provide mentoring/technical expertise to plant personnel by maintaining open communication and sharing of knowledge.
• Act as process owner and subject matter expert (SME) for the QA Process.
• Supports VP of Quality and Compliance in maintaining cGMP compliance.
• Approve validation documents related to facility or equipment user requirements or qualifications to ensure hygienic design is considered.
• Work collaboratively with manufacturing partners to develop robust cleaning and sanitization programs and provide training to operators on best hygiene and sanitization practices.
• Consult on and provide recommendations around sanitary design of manufacturing equipment, facilities and utilities.
• Conduct laboratory studies related to cleaning / sanitization procedures, plant hygiene, and investigations as needed.
• Documentation: Oversees and approves specifications for incoming raw material and finished goods, and protocols for validation / qualification of test methods to comply with compendium.
• Continuous Improvement: Supports identification of issues and concerns regarding Quality Assurance. Supports Quality and Compliance projects, in addition to initiatives and new business opportunities.
• Investigations: Investigates and documents issues that may affect product quality or productivity, generate corrective actions and oversee implementation.
• Internal Compliance: Audit internal processes and the manufacturing floor level for compliance to standards and reporting on compliance status.
• Training: Develops training as an outcome or extension of SOPs;
  Conduct GMP orientation/refresher training and act as a mentor to ensure understanding of and adherence to SOPs, GMPs and GDPs.
• Reconciliation: Manages and reviews the preparation and support storage of all batch records and ensuring all paperwork generated at the manufacturing level complies with GDP requirements.
• Supervision: A) Quality Assurance Supervisors;
  
  B) Quality Assurance Associates
  
  C.) IPQA Team
• Health & Safety: Ensuring all due diligence requirements and obligations under S.27 of the Occupational Health & Safety Act and all Company Standards, Policies, and Procedures are met and where possible exceeded; provide support and assistance to the Joint Health & Safety Committee in compliance with the JHSC Terms…