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.

For more information visit: www.apotex.com .

Job Summary Responsible for managing and ensuring the compliance of projects related to process and cleaning Validation, 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 process and cleaning validation programs remain 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..

Job Responsibilities

• Review/update the Process and Cleaning 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.
• Provide support and guidance in process and cleaning validation topics to our customers (e.g. Production, Facilities, Packaging, Engineering, Formulation Development), in problem solving and troubleshooting of validation issues and suggest CAPAs as required.
• Provide guidance and support for problem identification and resolution with validation protocols and reports.
• Performs technical assessments, to determine impact of changes to the Validation status, using the appropriate change control procedures (e.g. QMS Trackwise).
• Supports process and cleaning Validation topics during inspections (i.e., regulatory agencies, customers, internal or corporative audits).
• Perform data pull and analysys in JMP software for process and cleaning validation data.
• Perform data pull and analysys for stage 3A and 3B for process and cleaning validation projects to provide conclussions and recommendations for validation studies.
• 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.
• Oversees failures related to process or cleaning validation at a site level and ensures deviation investigations are initiated following existing procedure, as required.
• Via review/approval of process and cleaning validation protocols and reports, ensures that manufacturing/filling processes are maintained in a validated state of control. Provides notification of discrepancies and/or concerns to the departmental manager.
• Attends/supports meetings (i.e., launch, flightboard, Customer Services Board (CSB), Supplier Driven Change (SDC)) to communicate and provide guidance on validation impacts and strategies.
• As applicable, reviews change controls for Master Production and Packaging Documents for the appropriate validated parameters and supporting documentation. Reviews and approves impact of changes to the validation status, according to the applicable change control procedures (e.g., QMS Trackwise).
• Provides training on Process Validation, and Cleaning Validation topics to internal customers, as required.
• Assumes certain responsibilities of the Manager or Supervisor in their absence.
• 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

• Education

• Minimum B.Sc. / B.Eng (in related field) degree or equivalent.

• Knowledge, Skills and Abilities

• Experience in a liquid dosage manufacturing environment, with a strong understanding of TPD, FDA, EU and other applicable regulatory guidelines related to process and cleaning 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, a minimum of 4 years within a technical Validation role.

At Apotex, we are committed to fostering a welcoming andaccessible 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.