Quality Validation & Engineering Project Leader

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.