Evonik Canada Inc.

Pharmaceutical

Sr.ProjectManager,QualityAssurance(QA)

$102–135k Burnaby, British Columbia, Canada FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Pharmaceutical
Problems you'll solve

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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