Project Leader, MST Process Validation

Job Summary

Responsible for the development, tracking and execution of projects within the Portfolio.  The Project Leader is accountable to ensure all tasks and requirements related to projects are delivered through leading of various cross-functional teams and through timely escalation as required.

Collaborate with Stakeholders and all functional areas across the business to achieve successful project execution.  Provide status updates to the Supervisor, as required and notification of any potential project delays/risks as they arise.  Works directly with other department staff both internally and externally to capture and report on their projects. 

In addition, the Project Leader MST-Process Validation is responsible for managing and ensuring the compliance of projects related to Process Validation.. and for the review of proposed validation documentation and strategies which ensure the validation program remains compliant with the TPD, FDA, EU and other regulatory guidelines.  Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory requirements of validation for various departments such as Quality, Production, Regulatory Affairs and other subsidiary groups within MST Validation.

Job Responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage, Innovation
• 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.
• In the absence of the Supervisor, oversee daily operation of the Process Validation (PV) group by:
  • Ensuring that all protocols/reports are executed and approved in accordance with the department work schedule and guidelines
  • Ensuring that all validation team members are supported properly in order to ensure the customers deadlines are met
  • Providing guidance/support for problem identification and resolution with protocols and reports
  • Communicating and prioritizing projects with customers when conflicts or work scheduling issues arise
• Via review of PV protocols/reports, ensures the manufacturing processes are maintained in a validated state of control. 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.
• Provides day-to-day support, direction and guidance to the PV department and their customers (ex. Production, Supply Planning, Regulatory Affairs, QA, Formulations Development).
• Reviews proposed remedial and corrective actions related to deviations and other excursions from validation protocols.
• Assists as a consultant during investigations of out of trend/specification of validation data where appropriate.
• Leads PV projects and initiatives and communicates project status updates to management through the use of tracking sheets (Excel or MS Project).
• Attends/Supports change controls, focus meetings (customer service, API, launch,  site transfer),  to communicate and provide guidance on validation impacts and strategies.
• Participate in Departmental meetings including facilitation.
• Reviews validation strategies and associated documentation against the requirements of the Process Validation Master Plan (PVMP), to ensure that compliance and business needs are achieved.
• Reviews the PVMP for compliance with regulatory requirements.
• Reviews and provides feedback for Technical Reports related to Validation.
• Reviews all validation documents, protocols and reports to ensure a consistent harmonized validation approach in accordance with the requirements of the PVMP.
• Supports Validation during inspections by regulatory agencies.
• Main department liaison for all process capability related projects and daily departmental activities.
• Ensures that all work is performed in full compliance with Good Manufacturing Practices, Standard Operating Documents/procedures, established safety standards and regulatory requirements
• Acts as authorized designate for the Supervisor to review protocols and reports
• Reviews and provides feedback for SODs pertaining to validation activities.
• Working with the Supervisor, assists in coordinating the training of new employees
• Provides training on validation topics (including protocol requirements) to internal customers as required.
• Works as a member of a team to achieve all outcomes.
• Performs other relevant duties as assigned.

Job Requirements

• Education
  • Degree, Diploma or Certification in Chemistry, Pharmaceutical Technology  or related science
  • Demonstrated high level of knowledge, skill, or expertise in all validation concepts, with experience using statistical tools for evaluation of process capability and control.
  • Excellent oral and written communication skills.
  • Demonstrated ability to work effectively as a team member with employees at all levels of the organization.
  • Strong interpersonal skills.
  • Strong customer service orientation.
  • Excellent problem solving and troubleshooting abilities.
  • Ability to analyze and recommend process improvement.
  • Proven organizational, time management, and project management skills.
  • Intermediate to advanced computer skills in MS Excel, Word, Access, Microsoft Project, required.

• Experience
  • Minimum 5 years of pharmaceutical manufacturing experience.
  • Minimum of 3 years experience in a Validation role.