Quality Assurance Validation Project Leader

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

Responsible for managing and ensuring the compliance of projects related to Process Validation (including Sterile / Aseptic Process Validation) Cleaning Validation and Equipment and Facility Qualifications. Accountable for communicating status of these validation projects to the management group. Responsible for the review and approval of proposed validation documentation and strategies which ensure the validation program remains compliant with the TPD FDA EU Apotex SOPs and other regulatory guidelines. Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory requirements of the Validation requirements for various departments such as R&D Formulation Development Engineering Technical Operations Production Regulatory Affairs and other subsidiary groups within Quality.

Job Responsibilities

• Reviews the Validation Master Plans for compliance with regulatory requirements.
• Reviews validation strategies and associated documentation against the requirements of the Validation Master Plan to ensure that compliance and business needs are achieved.
• Acts as QA reviewer / approver / responsible on :
• Process Validation related protocols reports and other documents.
• Commissioning documents SATs FATs qualification protocols and reports Equipment & Facility Change Controls
• Preventative Maintenance & Calibration orders assessment and approvals as required.
• Calibration / Facility related failure Investigation
• Cleaning Validation related protocols reports and other documents.
• Technical Operations related protocols and reports (Demonstration Technical Transfer).
• Works closely with the Process Validation Equipment & Facility Qualification Cleaning Validation and Technical Operation groups to provide support and guidance to our customers (e.g. Production Facilities Packaging Engineering Formulation Development) in problem solving and troubleshooting of validation issues and suggest CAPAs as required.
• Performs technical assessments using the appropriate change control procedures (e.g. QMS Trackwise) and acts as QA approver where required.
• Act as QA SME for reviews / approvals of proposed remedial and corrective actions related to deviation investigation and other excursions related to out of trend / specification of validation / qualification data as required.
• Acts as a member of teams and / or committees such as new product launch Change Control Board to provide guidance related to validation regulations / guidelines.
• Participate in periodic reviews of Preventative Maintenance and Calibration trends.
• Via review / approval of Process Validation Protocols and Reports ensures that manufacturing / packaging processes are maintained in a validated state of control. Provides notification of discrepancies and / or concerns to the applicable departmental manager.
• As applicable reviews change controls for procedural changes. Reviews and approves impact of changes according to the applicable change control procedures (e.g. QMS Trackwise).
• Ensures that all work is performed in full compliance with Good Manufacturing Practices and Standard Operating Documents / procedures.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values : Collaboration Courage Perseverance and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program Global Quality policies and procedures Safety and Environment policies and HR policies.
• All other relevant duties as assigned.

Job Requirements

At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.

Required Experience :

Senior IC

Key Skills

ASP.NET,Asset,Information Security,Jboss,Budgeting,Accident Investigation

Employment Type : Contract

Experience : years

Vacancy : 1