Our client, a global leader in their field, is currently seeking a Technical Services Specialist - Pharmacy to join their team. Reporting to the Associate Director Technical Services & Affairs, the Technical Services Specialist - Pharmacy is responsible for planning, scheduling, coordinating and tracking the group's work activities. If you have minimum 5 years of experience in drug development, along with experience working with “solids”, formulation development, along with a degree in Pharmacy (or similar) with experience in production – we want to hear from you!

Responsibilities:

• Coach staff through the provision of regular feedback in the form of status meetings, objective setting sessions, performance appraisals, counselling, discipline and the assignment of projects. Manage the activities of all indirect reports to ensure timely and effective completion of projects and tasks.

• Provide guidance and coaching to the other members of the Technical Services Group.

• Effective root cause analysis to determine cause for failure results. Review, challenge and execute preferred process to improve the process to cost savings or reduce deviations or cycle time.

• Work independently with responsibility to accommodate frequently changing and urgent priorities.

• Coordinate general knowledge on investigations and changing regulatory and/or global requirements within the Technical Services for the continuous improvement of investigation quality and compliance.

• Evaluate and report on investigation trends and CAPAs implemented by the QA.

• Act as a resource person to team staff, management and internal customers with respect to project status and information flow

• Serve in a supervisory capacity and communicates department's objectives. Participate in developing action plans for the improvement of the org. unit

• Ensure that all advice given to the specifications group team members as well as internal/external contacts and highly complex decisions made at this level are compliant with regulations governing their work.

• Attend the Technical Review meetings and update status reports of activities for rework, conversion projects, alternate suppliers, international submissions and scale-up etc.

• Review and approve change controls/batch records in timely manner. 

• Participate in product improvement, process design, and validation meetings as a means to move projects forward.

• Responsible for the manufacture of submission batches related to alternate raw material suppliers for Canadian, EU and U.S. Markets (exhibition and CBE batches).

• Assist Regulatory Affairs Department for filing & submission requirements.

• Initiate, participate, supervise, oversee and successfully complete Process Improvements, Cycle Time Reduction, Cost Reduction, and Scale up, Alternate API qualification, Technology transfer & Submission projects and meet the deadlines.

• Participate in re-design/re-formulate existing products to maximize efficiency, capacity and quality.