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| Patheon Whitby Operations, with 192,700 square feet (17,900m2) of capacity, specializes in the contract manufacturing of solid and semi-solid dosage forms including powders, tablets, capsules and suspensions or liquids. Click on the directions icon for more information about this location and for driving directions. |
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Patheon has the following openings at this location:
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Manager Quality Control
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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.
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Manager, Quality Assurance
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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.
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Project Manager I (12 Month Contract)
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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
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