Quality Systems (QS) Specialist

at  Evonik

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 more…access 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:
https://www.youtube.com/watch?v=s5X15sKUEzs

REQUIREMENTS

BSc. in chemistry, biological/ applied sciences, pharmaceutical engineering, or equivalent, with

• 5 years of work experience in GMP regulated environment
• Minimum 2 years of such experience in the Quality unit.
• Work experience in microbiology and/ or sterile manufacturing would be an asset
• Auditing certification (e.g., CQA) would also be an asset
• Sound knowledge of cGMP requirements (e.g., Health Canada, FDA, ICH, EU and ISO) and experience in the application and interpretation of cGMP requirements.
• Detail oriented to assure accuracy of data and information.
• Excellent technical writing, problem-solving, and communication skills.
• Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently.
• Effective and professional interpersonal skills with abilities to influence others across multiple functions.
• Self-motivated with abilities to work in an undefined environment.
• Must be flexible and willing to provide off hours support, as needed to support GMP operations.

Your Application
To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our
careers
portal
. Further information about Evonik as Employer can be found at
https://careers.evonik.com
.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:
Robin Rose
Company is
Evonik Canada Inc

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 on-time delivery of products/ materials/ services that are quality compliant and fit for its intended purpose

Operational Excellence:

• Ensure the day-to-day 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:
• Provide independent and objective evaluation of internal GMP operational activities and external supplier qualification
• Collaborate with other NC-HC sites to efficiently utilize site resources to accomplish external supplier / vendor audits
• Be the Quality rep. to work with internal stakeholders to timely resolve supplier and raw material related issues
• Provide quality support and guidance for continuous process/ system improvement
• Develop, review and/ or approve GMP documents, as assigned/ delegated
• Be the site Trainer to provide on-boarding and refresher GMP training
• 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.
• Proactively develop training materials/ tools to assure effective training

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/ Non-conformance/ Change Controls and CAPAs to assure the actions and documentation are appropriate and completed in an accurate, adequate and timely manner.
• When required, actively participate in cross-functional team investigation and root cause analysis
• When required, lead as Change Controls and CAPA owner
• Participate in Quality Risk Management to support GMP operations
• Support internal and external audits
• Proactively participate in the preparation of internal and external audits