DUTIES:

• Manage and resource plan the QC lab operations for chemistry and microbiology.
• Coach and develop lab personnel and ensure that all GLP, GMP and corporate quality requirements are fully developed and maintained.
• Ensure testing for commercial products and products on stability are performed according to quality standards and schedules.
• Provide technical support and input to clients, Business Management, Project Management, Compliance and Operations. Provide expertise to investigate and resolve technical issues within the laboratory.
• Participate in the audits performed by external auditors, i.e. Canadian HPFBI, US FDA, corporate and third party.
•  Review and approve OOS reports.
• Provide leadership in determining corrective actions and resolution to address QC quality related issues.

Qualifications:

• Minimum B.Sc degree in Chemistry or related science.
• 8-10 years experience in Quality Control testing and a minimum of 3 years experience in a Supervisory/Management capacity.
• Strong camp, GLP and FDA compliance knowledge.
•  Excellent interpersonal, communication, leadership and organizational skills.

Duties:

• Direct investigations performed by Manufacturing/Packaging departments and evaluate all batches manufactured to ensure compliance with regulations.
• Involvement in the audits performed by external auditors, i.e. Canadian HPFBI, US FDA, corporate and third party.
• Function as a subject matter expert for quality issues in meetings & conference calls with clients
• Manage and schedule the work of QA Associates
• Review and approve validation protocols and reports
• Review and approve master manufacturing and packaging documents

Qualifications:

• Minimum B.Sc degree in Chemistry, Pharmacy, Microbiology or related science.
• Minimum 5 years relevant experience.
• Strong knowledge of Canadian Food & Drug Act, FDA/HPFBI & GMP regulations.
• Excellent problem solving skills including FMEA/Risk assessments.
• Excellent interpersonal, communication and organizational skills.

Duties:

• Manage multiple development projects for Patheon Pharmaceutical Development Services (PDS) clients. 
• Plan, monitor and ensure completion of all activities outlined in the client quote for each project. 
• Make recommendations to clients on drug development and regulatory guidelines.
• Facilitate positive team member interactions internally and with client.
• Establish/practice standard project reporting procedures to client and management
• Manage client relationship and expectations.
• Prepare amendments for changes of scope.
• Create and maintain client timelines within Microsoft Project.
• Other Duties as Assigned

Qualifications:

• Minimum B.Sc.
• Minimum 3 -5 years industry experience preferably in pharmaceutical industry
• One to two of the following:
• 2-5 years pharmaceutical development experience
• 3-5 years Project Management experience
• 3-5 years Client Management experience
• Well organized and detail oriented, ability to prioritize multiple project deliverables
• Strong interpersonal skills, as well as the ability to motivate and influence; client interface experience and strong negotiating skills are an asset
• Excellent written and oral communication skills
• Ability to work both in a team environment as well as independently as required
• Proficiency with MS office programs