PE Stability Coordinator (R&D)

Apotex•Richmond Hill, ON

4d•CA$55,138 - CA$77,193

About The Position

Responsible for the coordination of the pre-marketed stability program within Global R&D, and for the preparation of stability samples for ICH stability study 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 advice management team members on deviations, alarms associated with various reah-in and walk-in stability chambers.

Requirements

Bachelor’s Degree or Diploma in Chemistry, Biology, Pharmaceutical and/or Health Science
Strong working and theoretical knowledge of ICH Guidelines as it pertains to NPD and PLCM 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, 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.

Nice To Haves

Working knowledge of analytical laboratory techniques an asset.
Experience directly related to product stability evaluation and with automated systems for the management of stability programs is an asset.

Responsibilities

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 each stability conditions for the ongoing stability studies to ensure that sufficient samples are available. Notify Manager of any concerning discrepancies detected.
Reviews and evaluates monthly reconciliation of controlled substances used in the stability studies with appropriate documentation as per the relevant SOP’s
Prepares and provides stability samples, for internal or external customers. Act as a back-up for RLD samples maintenance and upkeep for receiving and distributing to various department with R&D Liquid Dose.
Performs stability samples reconcillations for completeness and compliance as per SOP.
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 for managing and maintaining stability chambers and alarms associated with them.
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.
Liase with building service management personnels and technicians in maintain reac-in and walk-in stability chambers.
Involved in the creation and management of alarm acknowledgement logs for the stability chambers by liasing with building service technicians
Liaises with LIMS Operations, Product Evaluation, Formulations Development and colleagues in Analytical Development, Pre-formulation Development 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 revision for stability test profile is completed.
Logs all Environmentally Control Chamber alarms from Building Systems and performs quarterly alarms reconciliation.
Works with Manage and SupervisorProduct Evaluation to improve departmental processes and SOP’s.
Provides weekly status updates to the Manger, Product Evaluation
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.
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.