Evonik Canada Inc.
Pharmaceutical
Sr.ProjectManager,QualityAssurance(QA)
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. Project Manager, Quality Assurance (QA) at Evonik Canada Inc.. Skills: Quality Assurance, GMP, Quality Systems. Maintain and revise QA procedures. Maintain cGMP training systems”
Industry & Context.
Root Cause Analysis
What They're Looking For.
Must Have
Senior QA level knowledge, Advanced supervisor level expertise, Advanced knowledge of GMP requirements, Advanced knowledge of Quality Systems
Nice to Have
Senior fluency in quality risk management principles, Ability to mentor others in Quality Risk Principles
What You'll Do.
Maintain and revise QA procedures
Maintain cGMP training systems
Perform on-site team member training
Ensure GxP support and oversight
Support QA team members
Perform QA batch record review
Disposition manufactured early phase clinical product batches
Provide final QA approval of investigations
Disposition impacted product batches
Propose batch rejections
Perform QA review and approval of environmental monitoring
Perform QA review and approval of Clean Utility
Perform QA review and approval of non-conforming product
Perform QA review and approval of out of
Manage and approve Change Controls
Manage and approve CAPAs
Manage and approve Deviations
Provide QA resources to support process development teams
Perform internal audits
Support internal audits
Perform qualification of suppliers
Support qualification of suppliers
Perform QA review and approval of facility qualification
Perform QA review and approval of equipment qualification
Perform QA review and approval of cleaning verification
Perform QA review and approval of analytical test
Provide QA review and approval of analytical methods
Provide QA review and approval of analytical standards
Provide QA review and approval of analytical specifications
Support customer audits
Coordinate customer audits
Lead improvement areas
Support definition of standards
Quality with setting annual QA priorities
Facilitate cross-functional team activities
Lead collaboration within organization
Support and develop peers
How You'll Work.
Team & Collaboration
Cross-functional team activities; Collaboration within organization
Communication Scope
Active listening
Process & Methodology
Change Control, CAPA, Deviations, Risk Assessments
Full Job Description
**Note: This is an on-site role with the flexibility to work from home in accordance with Evonik 's Smart Work Program. ** Target Salary Range: $101,500 – $135,300 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data) **EVONIK** Vancouver Laboratories (VAN), the operating drug delivery service site of Evonik Canada Inc., is a Contract Development and Manufacturing Organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies engaged in the development and manufacture of complex delivery-based drug formulations. **EVONIK** has a successful track record of helping Customers move their programs forward. Evonik’s Vancouver business operations is a development partner to the world’s pharmaceutical companies for parenteral lipid nanoparticle drug products. As an enabling contract development manufacturing organization (CDMO) partner, we offer drug formulation design, process development, scale-up, and clinical production. **EVONIK’s** range of services extends from initial formulation prototype identification, manufacturing process development & scale-up, analytical method development & validation to support raw material, in-process, release and stability testing, all the way through to sterile product manufacturing under GMP for Phase I-II clinical trials. Products include the LIPEX® line of Extruders, which are designed to enable small-scale to commercial scale manufacturing of liposomal drug products. With over 25 years of experience and having transacted business in about 50 different countries, **WHY EVONIK?** Evonik offers an excellent Total Rewards Program including: Competitive base compensation & bonus; employer paid health & dental benefits complimented with wellness education sessions; Financial planning resources & savings plans including RRSP & Defined Contribution pension plans; Generous vacation and paid time off to support Com
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