Sr. Technical Services Specialist Of Drug Formulation

Title – Senior Technical Services Specialist (Drug Formulation)

Structure – Permanent Employment

Location – Stoufville or Scarborough

Industry – Pharmaceutical

DESCRIPTION

• Our client is currently seeking a Technical Services Specialist to join our team. Reporting to Associate Director Technical Services & Affairs, tech Specialist is responsible for planning, scheduling, co-ordination and tracking the group's work activities.

RESPONSIBILITIES

• Act as a resource person to team staff, management and internal customers with respect to project status and information flow
• Responsible for the manufacture of submission batches related to alternate raw material suppliers for Canadian, EU and U.S. Markets (exhibition and CBE batches).
• Effective root cause analysis to determine cause for failure results.
• Attend the Technical Review meetings and update status reports of activities for rework, conversion projects, alternate suppliers, international submissions and scale-up etc.
• 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.
• Coach staff through the provision of regular feedback in the form of status meetings, objective setting sessions, performance appraisals, counseling, discipline and the assignment of projects.
• Work independently with responsibility to accommodate frequently changing and urgent priorities.
• Serve in a supervisory capacity and communicates department's objectives.
• Review and approve change controls/batch records in timely manner
• Evaluate and report on investigation trends and CAPAs implemented by the QA.
• Provide guidance and coaching to the other members of the Technical Services Group.
• Participate in developing action plans for the improvement of the org. unit
• 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.
• Participate in product improvement, process design, and validation meetings as a means to move projects forward.
• Review, challenge and execute preferred process to improve the process to cost savings or reduce deviations or cycle time.
• Assist Regulatory Affairs Department for filing & submission requirements.
• Manage the activities of all indirect reports to ensure timely and effective completion of projects and tasks.