job title: Executive, stability lab(documentation)(apotex)

Roles and 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