Quality Assurance Manager

If you are seeking the challenge of being the quality assurance leader for a small manufacturing plant that is part of a growing bio-pharmaceutical manufacturer, this is the job for you! As the Quality Assurance Manager, you will be responsible for managing the quality assurance, regulatory and environmental programs for Dextran Product's Scarborough, Ontario Facility.

• Quality Management System: Maintain and implement the requirements of the quality management system throughout the facility and processes.
• Raw Material, In-Process & Final Product Review & Release:
• Raw Material - Review raw material testing record and issues material disposition. Manages raw material supplier qualification process.
• Material Disposition - Issue and approve material disposition. Approve product related records, analysis request and BOMs in Sage.
• Final Product - Issue, Review and approve batch production records, reviews finished product results documentation, analysis record and issues and approves Certificate of Analysis (C of
  
  A), and prepares and issues labels for final release.
• Facility Inspection:Perform recurring quality inspection of the facility to ensure compliance to standards, applicable regulations and internal procedures. Ensure facility is maintained and systems are clean and ready for use through inspection, providing recommendations, communicating findings and tracking completion of corrections.
• Documentation Review, Revision & Retention:
• Document Review & Revision - Prepare, review, revise and approve documentation and procedures including blank product batch records, SOPs, test records and analysis, log books, instrument calibration reports, IQ/OQ protocols.
• Record Review & Retention - Review and Approve GMP records including batch records, forms, log books, laboratory records, investigations, CAPAs and other forms of GMP documentation. Ensure that documents are retained in accordance with the Company policies and Quality Management System.
• Corrective Action, Internal Audits and Change Control:
• CAPA & Internal Audits - Manage CAPA & internal audit programs; and lead out-of-specification investigations.
• Change Control - Manage Change Control process, determine change classification and initiate customer notification.
• Customer Complaints, Audits & Recalls:
• Manage customer complaint process, lead customer audits, including generating audit responses and CAPA, complete customer questionnaires and investigate and manage product recalls.
• Host and prepare for customer and regulatory audits.
• Stability Program Management
  :
  Develop program with procedure/protocols, monitor conditions, review on-going sampling results, investigate OOS results and establish product shelf life.
• Regulatory Program:
• Manage Dextran's regulatory program to ensure compliance with internal SOPs and external regulations.
• Ensure accurate and complete documentation is provided in support of product commercialization.
• Annual Product Review:Perform annual product reviews, generate reports based on in-process and finished product analysis.
• Environmental Health and Safety
  :
  Ensure compliance to environmental policy and reporting requirements. Ensure compliance to the company’s health and safety programs through procedure review and approval. Perform safety inspections during the required frequency, document and communicate findings and ensure corrective and preventative actions are completed in a timely manner.
• Training
  :
  Conduct training for new hires, training on SOPs and changes, retraining and quality systems training.
• Pest Control
  :
  Manage, review and approve documentation related to the plant's pest control program.

• Education
  :
  
  Bachelor’s degree in Chemistry, Chemical Engineering or related field or the equivalent in related experience.
• Experience
  :
• Five or more years of experience managing multiple elements of a quality assurance quality assurance and/or compliance program within a GMP chemical manufacturing facility. The ideal candidate will have a familiarity with IPEC regulations and guidelines.
• The ideal candidate MUST have experience understanding and working with chemical compounds and ingredients as well as…