3 Key Consulting is hiring Senior Project Managerfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: Onsite at Canada location; North of Toronto (site in Whitby ON Canada)
With minimal supervision apply process operational scientific expertise basic compliance knowledge and analytical and troubleshooting skills to support manufacturing operations.
Responsibilities include but are not limited to the following:
Act as technical ADVISOR to manufacturing team
Support the of manufacturing/quality systems such as deviations CAPAs change controls procedures training and new product introductions
Provide oversight of production runs and closely monitor high risk operations as defined by the risk assessments
Successfully detect identify & resolve issue/defect through inplace Quality systems
Communicate newly identified risks during operation or in related Quality System documents / procedure / practices
Act as primary client contact while on site for any troubleshooting during production
Escalate as needed per escalation process
Collect information and data as provided by the local team to facilitate effective communication with the extended team
Provide periodic update on the status of the campaign
Identify optimization/improvement opportunities for the future activities
Why is the Position Open Team need/ backfill
Top MustHave Skill Sets:
Quality records experience; deviation process. etc required
Detailed technical understanding of Oral Solid Dosage (OSD) DP/FDP unit operations
Skilled in performance of GMP production operations
Ability to communicate and collaborate with technical and management staff within manufacturing process development and quality
Organizational technical writing and presentation skills
Regulatory knowledge and interactions
Day to Day Responsibilities: Including but not limited to providing oversight of DP and FDP production
Employee Value Proposition: Growth/ opportunity
Red Flags: Must have GMP Knowledge. Must be able to work with 3rd party vendors/ suppliers
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
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