Job Description

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, Cleaning Validation, Equipment and Facility Qualifications, Computer Systems Validation, New Product Launch, Manufacturing Technical Services process modifications and Maintenance. Accountable for communicating status of these validation projects to management and supporting departments. 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. Takes a leadership role within the team, acting as a subject matter expert for validation-related investigations, ensuring projects are on track and assuming some decision-making responsibility.
Job Responsibilities

• Reviews and adheres to the Validation Master Plans (VMP) for compliance with regulatory requirements
• Reviews validation strategies and associated documentation against requirements of the VMP to ensure that compliance and business needs are met
• Acts as QA reviewer/approver on:

• Process Validation (PV) protocols, reports, Change Controls Records (CCR) and other documents
• Commissioning documents (e.g. SAT, FAT, qualification protocols), Engineering CCRs, Preventative Maintenance (PM) & Calibration orders, Building Systems investigations and other documents
• Cleaning Validation (CV) protocols, reports and other documents
• New Product Launch (NPL) and Manufacturing Technical Services (MTS) protocols and reports and other documents
• Computer Systems Validation (CSV) protocols, reports and CCRs

• Works with PV, Equipment & Facility Qualification (EFQ), CV, CSV, MTS and MTS to provide support and guidance to customers (e.g. Production, Facilities, Engineering, Formulation Development).Acts as QA SME for review/approval of proposed remedial and corrective actions related to deviation investigation and other excursions related to validation/qualification data, as required. Ensures that proposed CAPA are assessed for validation impact
• Acts as a member of teams/committees such as New Product Launch, Change Control Board to provide guidance related to validation
• Participates in periodic review of Preventative Maintenance (PM) and Calibration trends and proposes program enhancements as required
• Conducts audit-based review of PM program.
• Via review of PV protocols/reports, ensures that manufacturing/packaging processes are maintained in a validated state of control; provides notification of discrepancies/concerns to management
• Reviews Master Manufacturing and Packaging Records CCRs for appropriate validated parameters and supporting documentation. Reviews/approves impact of changes to validation status, according to the applicable procedures
• Supports QA and Validation during inspections
• Reviews and provides feedback for SODs pertaining to validation activities
• Promotes environment of continuous improvement through active leadership of cross-functional projects and initiatives
• Immediately raises concerns to management
• Assumes certain responsibilities of management in their absence, taking on some decision-making duties, leveraging experience and knowledge
• Ensures that all work is performed in full compliance with Good Manufacturing Practices and SODs/procedures
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values:Integrity, Teamwork, Courage, , and Innovation

All other relevant duties as assigned
Job Requirements

• Education

• Bachelor of Science/ Engineering or equivalent.
• Knowledge, Skills and Abilities

• Experience in a solid dosage manufacturing environment, with a strong understanding of TPD, FDA, EU and other applicable regulatory guidelines related to Validation.
• Demonstrated high level of knowledge, skill, or expertise in validation concepts, with experience using statistical tools for evaluation of process capability and control.
• Proven organizational, time management, and project management skills.
• Knowledgeable user of SAP and TrackWise systems.
• Ability to analyze systems and processes and recommend process improvement.
• Excellent problem solving and troubleshooting abilities.
• Excellent oral and written communications.
• Strong interpersonal skills.
• Demonstrated ability to work effectively as a team member with employees at all levels of the organization.
• Ability to work independently with minimal supervision.
• Strong customer service orientation.
• Working knowledge in the use of Microsoft office tools or similar software.
• Experience

5+ years of pharmaceutical manufacturing experience with a minimum of 4 years within a technical Validation role.
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.

Skills Required