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Quality Systems (Qs) Specialist
Company | Evonik |
Address | Burnaby, British Columbia, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Chemical Manufacturing |
Expires | 2023-08-21 |
Posted at | 9 months ago |
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.
- 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
- Provide quality support and guidance for continuous process/ system improvements
- Support site internal project(s) and temporary assignment(s) as assigned by Quality Management.
- Be the Quality rep. to work with internal stakeholders to timely resolve documentation, training and other QS related issues
- 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.
- Provide Quality system support for client funded and internal projects, including but not limited to:
- Develop training materials / tools to assure effective training
- Ensure the day-to-day Quality systems related activities are performed efficiently and effectively in accordance with approved SOPs, GxP and EHSS requirements.
- Develop, review and/ or approve GMP documents, as assigned/ delegated
- Implement / maintain electronic documentation and learning management systems in collaboration with NC-HC sites
- Support internal and external audits
- Participate in Quality Risk Management to support GMP operations
- Proactively participate in the preparation of internal and external audits
- 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, lead as Change Controls and CAPA owner
- Develop, maintain and update applicable Quality related SOPs to assure the procedures are compliant with GMP, EHSS and company requirements.
- Be the area subject matter expert (for function) in responding to internal and external audit requests
- When required, actively participate in cross-functional team investigation and root cause analysis
- Complete all required EHSS training and remain current with applicable learning plans.
- Assume personal accountability for individual behaviors related to EHSS activities
- Report all injuries within the same shift of the incident occurring.
- Adhere to all EHSS programs, rules, and procedures of Evonik
- Inform direct supervision of any EHSS hazards or concerns in the workplace.
- Have appropriate knowledge, training and tools (e.g., don applicable PPE) prior to performing a task.
- Effective and professional interpersonal skills with abilities to influence others across multiple functions.
- Auditing certification (e.g., CQA) would also be an asset
- Excellent technical writing, problem-solving, and communication skills.
- Ability to perform work utilizing a computer for extended periods of time.
- Experience in change management or lean transformation an asset.
- Detail oriented to assure accuracy of data and information.
- Minimum 2 years of such experience in the Quality unit.
- Work experience in microbiology and/ or sterile manufacturing would be an asset
- Must be flexible and willing to provide off hours support, as needed to support GMP operations.
- Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently.
- BSc. in chemistry, biological/ applied sciences, pharmaceutical engineering, or equivalent, with ≥ 5 years of work experience in GMP regulated environment
- Proficient in computing (e.g., Microsoft Word, Excel, PowerPoint, Visio, etc.).
- Self-motivated with abilities to work in an undefined environment.
- Sound knowledge of cGMP requirements (e.g., Health Canada, FDA, ICH, EU and ISO) and experience in the application and interpretation of cGMP requirements.
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