Job Title

Overview Job Title: Project Manager Senior, BiopharmaManufacturing (JP10103) Location: Edmonton, Alberta, CAN T6X2B7 Employment Type: Contract Business Unit: ACDM Synthetics DP/FDP Duration: 8 months with likely extensions Posting Date: 04/21/2022 3 Key Consulting is hiring Senior Project Manager for 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 - Act as technical ADVISOR to manufacturing team - Support the execution 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 in-place 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 Must-Have 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 Interview process Pls expect 4-6 interviews: Groups: ACDM, QA, Packaging PD, DP-PD How to apply We invite qualified candidates to send your resume to [email protected]. If you decide that youre not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr