Technical Services Specialist - Pharmacy
Greater Toronto Area, ON CA
Our client, a global leader in their field, is looking for a Technical Services Specialist - Pharmacy to join their team. The Technical Services Specialist will report to the Associate Director Technical Services & Affairs and will be responsible for coordinating and tracking the group's work activities. The ideal candidate should have at least 5 years of experience in drug development, formulation development, and production of solids with a Pharmacy degree or similar qualifications. This is an excellent opportunity for a Technical Services Specialist with experience in drug development and formulation development to join a global leader in their field. If you meet the qualifications, we encourage you to apply for this exciting position.
- Provide coaching, guidance to team members to ensure timely and effective completion of projects and tasks.
- Present regular feedback to staff through status meetings, objective setting sessions, performance appraisals, counselling, discipline, and project assignments.
- Conduct root cause analysis to determine the cause of failures, then review results and recommend solutions to improve processes and reduce deviations or cycle time.
- Keep up to date with regulatory requirements and share general knowledge with the Technical Services group to improve investigation quality and compliance.
- Work independently with responsibility to accommodate frequently changing and urgent priorities.
- Act as a resource person to team staff, management, and internal customers regarding project status and information flow.
- Serve in a supervisory capacity and communicate department objectives, as well as participating in developing action plans to improve the organizational unit.
- Ensure that all advice given to the specifications group team members and internal/external contacts, as well as all highly complex decisions made at this level, are compliant with regulations governing the work.
- Attend Technical Review meetings, update status reports, review and approve change controls/batch records, and participate in product improvement, process design, and validation meetings.
- Participate in product improvement, process design, and validation meetings as a means to move projects forward.
- Initiate, participate in, supervise, oversee, and successfully complete Process Improvements, Cycle Time Reduction, Cost Reduction, Scale-up, Alternate API qualification, Technology transfer and Submission projects, and ensure deadlines are met.
- Participate in re-design/re-formulate existing products to maximize efficiency, capacity, and quality.
- Bachelor's or Master's Degree in Pharmacy, Chemical Engineering, or a related science.
- 5-7+ years of experience in drug development, formulation development, production of solids, controlled release dosage forms.
- Demonstrated expertise in product development, process development, process validation, and GMP.
- Sound knowledge of ICH, Canadian and U.S. regulatory guidelines and quality assurance.
- Excellent command of the English language, both verbal and written.
- Highly organized and capable of handling multiple technical projects concurrently within a cross-functional team environment.
- Self-starter who can work with minimal supervision with strong leadership skills.