Stability Planner

**Stability Planner**
Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry.
Responsible for the for the effective initiation, administration, monitoring and closure of CPL initiated stability programs for R&D, PD and Commercial Departments
**SPECIFIC RESPONSIBILITIES**:

- Maintains responsibility for physical control and movement of stability sample lifecycle, including receipt, labelling, reconciliation, storage, pulls, interim storage before and after analysis, and stability sample disposal.

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Ensures samples are appropriately and accurately identified, labeled, reconciled, stored, logged and tracked to maintain sample integrity, current inventory records and accurate chain of custody from receipt through disposal. Identifies and facilitates the resolution of any discrepancies with samples and documentation to allow laboratory work to proceed correctly and on-time.

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Prepares stability protocols, associated change controls, Interim Stability Summary Report master worksheets, and liaises with multiple departments to get all documents approved for the timely initiation of stability programs.
- Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by CPL; reports any injury or illness immediately and notifies CPL of any hazards, unsafe acts or conditions in the workplace.

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Acquires information from internal and external cross-functional teams (clients, PDS, TT, Account Managers, and Project Leaders) as applicable for the preparation of stability protocols.

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Ensures that all regulated operations in area of responsibility are adequately described by written procedures and that all operations are performed according to the written procedures (SOPs, Protocols, Quality Agreement, etc.). Participates in the creation, review and approval of required documentation.

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Verifies / checks that all methods and revisions specified for test or stability samples correspond to those that have been appropriately transferred to, or validated by CPL. Identifies discrepancies and reports on same to supervisor.
- Participates in the ongoing monitoring of stability chambers. Writes stability chamber related deviations, assesses sample impact and delivers this information to appropriate CPL contact to gain approval from the customer.

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Prepares required documentation, establishes testing priorities and assigns due dates based on stability pull schedules, sample receipt dates, customer identified priorities, special requests and existing commitments.
- Allocates samples and documentation for Analytical and/or Microbiological testing as according to stability pull schedule. Maintains stability testing schedules to allow revenue forecasts and prediction of laboratory team workload.

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Maintains awareness of upcoming work and provides information to Stability Supervisor to allow for optimum allocation of resources to meet commitments.

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Participates in the creation and implementation of Lean initiative and continuous improvement strategies to measure and improve the efficiency of the stability program and testing.,

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Liaises with external laboratories for stability testing, sends samples, follows up on results and reports to meet QC target release timelines
- Other duties as assigned

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QUALIFICATIONS: *
- Bachelor of Science Degree in a chemistry or related field, combined with minimum 3 years of pharmaceutical industry experience in a GMP setting.
- Good understanding and knowledge of current regulatory (Health Canada, FDA, ICH) and pharmacopoeial requirements for release and stability testing of pharmaceutical materials and products.
- Strong written and verbal English communications skills.
- Ability to obtain and integrate information from multiple sources efficiently.
- Good working knowledge of Microsoft Office programs, especially Excel and Word.
- Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.

**PHYSICAL DEMANDS AND WORKING CONDITIONS**:

- Office work with computers with occasional exposure to laboratory work conditions. Lab presence requires use of protective equipment, such as safety glasses, lab coat and appropriate footwear, to reduce personal exposure and injury.
- Moving and pulling samples in and out of chambers requires reaching/bending and light lifting on a daily basis.
- Flexibility in hours of work to address emergency issues outside of normal workday.

We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.