Quality Assurance Validation Project Leader at Apotex Corp United States

Richmond Hill, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

0.0

Posted On

01 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Cleaning Validation, Equipment Qualification, Regulatory Compliance, Project Management, Problem Solving, Statistical Analysis, Technical Documentation, Interpersonal Skills, SAP, TrackWise, Good Manufacturing Practices, Change Control, Team Collaboration, Customer Service Orientation, Microsoft Office

Industry

Pharmaceutical Manufacturing

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. For more information visit: www.apotex.com.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 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 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 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.

Responsibilities

The Quality Assurance Validation Project Leader is responsible for managing compliance of validation projects related to Process Validation, Cleaning Validation, and Equipment Qualifications. They communicate project statuses to management and ensure validation documentation meets regulatory guidelines.