Quality Systems - Burnaby, Canada - Evonik

Evonik
Evonik
Verified Company
Burnaby, Canada

1 month ago

Sophia Lee

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Sophia Lee

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Description

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 Community Volunteer activities; Financial assistant for fitness memberships.

And there is to a Comprehensive Health Promotion program and Regional and Global resources for ongoing training and development.

Best of all, you will work within a great team of professionals in an engaging workforce who value trust and openness.

Are you looking to join a dynamic company with an exciting and expanding future in the pharmaceutical industry? Then Evonik is the next step in your career.

Grow with us

Click here to learn more from our Vancouver Laboratories employees:
WHY VANCOUVER?

Vancouver has something for everyone British Columbia is beautiful and exciting. From the people, to the mountains, to the sprawling coastline, everywhere you look. Nestled on the warm Pacific Coast with the Rockies blocking cold arctic winds. Vancouver has the good fortune of being spared the typically chilly winters associated with Canada.

Vancouver is often called 'two cities in one' because people are equally prone to enjoy the bustling nightlife and experiencing a plethora of activities in the surrounding nature.

Imagine enjoying a day-long trek through our world-renowned rain forests, then heading into the city for a night out. Vancouver truly is as beautiful as people say and more.


RESPONSIBILITIES

Leadership/ Functional:

  • Be a strong Quality partner/ collaborator to drive operational efficiencies to achieve sustainable quality compliance and meet the business objectives of the site
  • Build strong relationships with the Quality team, internal stakeholders (such as Development & Formulation, Supply Chain, Project Management, _etc_.) and external suppliers to assure ontime delivery of products/ materials/ services that are quality compliant and fit for its intended purpose

Operational Excellence:

  • Ensure the daytoday Quality systems related activities are performed efficiently and effectively in accordance with approved SOPs, GxP and EHSS requirements.
  • Provide Quality system support for client funded and internal projects, including but not limited to:
  • Implement / maintain electronic documentation and learning management systems in collaboration with NC-HC sites
  • Provide quality support and guidance for continuous process/ system improvements
  • Be the Quality rep. to work with internal stakeholders to timely resolve documentation, training and other QS related issues
  • Develop, review and/ or approve GMP documents, as assigned/ delegated
  • Stay abreast of current regulatory (e.g., ISO, ICH, FDA, EMA and Health Canada) & industry guidelines on topics such as aseptic manufacturing, GDP, GLP, Data Integrity _etc_.
  • Develop training materials / tools to assure effective training
  • Support site internal project(s) and temporary assignment(s) as assigned by Quality Management.

Quality Compliance:

  • Develop, maintain and update applicable Quality related SOPs to assure the procedures are compliant with GMP, EHSS and company requirements.
  • Assure all data and records are accurate, documented and maintained effectively and in compliance with Good Documentation Practice (GDP) and data integrity requirements
  • Support/ review Deviation/ Nonconformance/ Change Controls and CAPAs to assure the actions and documentation are appropriate and completed in an accurate, ad
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