Executive, Stability Lab (Documentation)

Job Summary

Responsible for the coordination of the pre-marketed stability program within Global R&D, and for the preparation and review of stability data evaluation reports (e.g., Executive Stability Report, Statistical Evaluation Report, etc.) for regulatory submissions. In a senior role, works closely with other team members, and is accountable for ensuring that stability programs are compliant with current regulatory requirements. Acts as an area SME during regulatory inspections, and for TrackWise Change Control, QMS Deviation and CAPA management systems.

Job Responsibilities

• Designs, prepares, and reviews stability protocols for R&D QA pre-approval.
• Evaluates analytical methods to determine suitable quantities of product for stability studies based on the corresponding testing plan.
• Reviews and evaluates stability data for the ongoing stability studies to ensure that significant trends that warrant attention are evaluated. Notify Manager of any concerning trends detected.
• Prepares, reviews, and publishes Stability Summary Reports, Executive reports, Shelf-life extension reports, Statistical evaluation reports, etc. within compliance time frame.
• Prepares and provides stability summary reports, including trend analysis and product evaluations for internal or external customers.
• Performs review of stability summary data provided by third party affiliates (e.g., contract laboratories) for completeness and compliance.
• Provides day to day technical support, direction, and guidance to the R&D Stability team members, including problem solving and troubleshooting of stability program related issues, and suggests remedial and corrective actions, when required. Acts as an area SME on TrackWise - Deviation and CAPA management system.
• Proficient in creating and verifying stability protocols in LIMS, and initiating stability studies.
• Prepares and oversees the execution of the monthly stability pull schedule, and assists with the preparation of different stability status reports, including the monthly reports.
• Involved in the creation and management of departmental change controls within the QMS Trackwise system.
• Liaises with LIMS Operations, Formulations Development and colleagues in Analytical R&D to ensure that all information required for stability protocol is complete.
• Provides information regarding the R&D stability studies to Formulation Development, Global Regulatory Affairs and other internal/external customers.
• Performs specification updates to all active stability studies within Labware LIMS when a change control for stability test profile is completed.
• Logs all Environmentally Control Chamber alarms from Building Systems and performs quarterly alarms reconciliation.
• Works with Manger, R&D Stability to improve departmental processes and SOP’s.
• Provides weekly status updates to the Manger, R&D Stability.
• Shares knowledge with team members and across R&D. Provides cross training and support to new team members.
• Monitors training progress and ensures all training gaps are completed within MyHR for Documents, GMP, Safety, Technical and Software courses.
• Works as a member of the team to achieve all desired quality/compliance outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensures 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, including back-up for coordinator role.

Job Requirements

• Education/Experience
  • A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Strong working and theoretical knowledge of ICH Guidelines as it pertains to NPD Regulatory submissions.
  • Thorough understanding of GMP and GLP guidelines and related SOPs and their application in a laboratory setting.
  • Proficiency commensurate with job requirements in Labware LIMS, QMS Trackwise, , Word, Excel, and other Windows software packages.
  • Proven organization and time management skills, as demonstrated through previous work and/or educational experiences.
  • Logical and detail-oriented personality with problem solving skills.
  • Ability to handle multiple work assignments and priorities in a fast-paced environment.
  • Ability to work independently with minimal supervision.
  • Excellent written and verbal English communication skills.
  • Well balanced interpersonal skills.
• Experience
  • 6+ year experience in pharmaceutical industry, preferably including experience in project management and coordination of work assignments.
  • Experience directly related to product stability evaluation and with automated systems for the management of stability programs is an asset