Job Description

What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

Click on the link below to learn what our employees have to say about Evonik:

RESPONSIBILITIES

Leadership/ Functional:

• Be a strong Quality partner/ collaborator to drive validation excellence to achieve sustainable quality compliance and meet the business objectives of the site
• Build strong relationships with the Quality team (including QS and QC), internal stakeholders (such as Facility Engineering, Manufacturing, Operations, Project Management, corporate subject matter experts (SMEs), etc.) and external suppliers/ service providers to assure on-time delivery of tasks and projects that are quality compliant and fit for its intended purpose

Operational & Validation Excellence:

• Ensure the day-to-day Quality Operations activities related to GMP qualification, validation, maintenance, and applicable data analysis/ trending are performed efficiently and effectively in accordance with approved SOPs, GxP and EHSS requirements, for example:

• Be the Quality rep. to work with internal stakeholders to timely develop, review and approve all qualification/ validation strategies, master plans, protocols, and reports in accordance with regulatory/ industry and Evonik\xe2\x80\x99s requirements and guidance
• Be the site quality compliance SMEs to participate in and provide objective evaluation of the design, qualification/ validation, maintenance, and data monitoring that fits for purpose of GMP manufacturing of sterile materials/ products. The topics are but not limited to the following:

• Facility related (e.g., appropriate air exchanges, pressure cascade, personnel & equipment flows, etc.)
• Utilities related (e.g., for potable water/ purified water/ Water for Injection/ clean steam/ compressed gas systems, etc.)
• Equipment, including sterilizer/ autoclave/ cleanroom equipment train for the entire aseptic filling process, etc.
• Sterilization (moist and dry heat sterilization, depyrogenation, sterilizing filtration, etc.), cleaning and disinfection
• Aseptic processes (including smoke studies and media fills)
• Cleanroom environments (ISO 8 to ISO 5)
• Computerized systems (including GMP systems for analytical testing in QC)
• Pest control
• Provide quality support and guidance for continuing QO related process/ system improvement
• Develop, review and/ or approve GMP documents (including applicable training materials), as assigned/ delegated
• 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/ 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 and applicable gap analysis to support GMP operations
• Support internal and external audits
• Proactively participate in the preparation of internal and external audits
• Be the area subject matter expert (for the responsible activities) in responding to internal and external audit requests/ findings

Environmental, Health, Safety, and Security (EHSS):

• Adhere to all EHSS programs, rules, and procedures of Evonik
• Assume personal accountability for individual behaviors related to EHSS activities
• Have appropriate knowledge, training, and tools (e.g., don applicable PPE) prior to performing a task.
• Complete all required EHSS training and remain current with applicable learning plans.
• Report all injuries within the same shift of the incident occurring.
• Inform direct supervision of any EHSS hazards or concerns in the workplace.

REQUIREMENTS

• BSc. in chemistry, biological/ applied sciences, pharmaceutical engineering, or equivalent, with \xe2\x89\xa5 8 years of qualification/ validation experience in GMP regulated environment
• Minimum 2 years of such experience in the Quality unit.
• Minimum 2 year of qualification/ validation experience in a sterile manufacturing environment
• Work experience in microbiology would 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.
• Ability to perform work utilizing a computer for extended periods of time.
• Proficient in computing (e.g., Microsoft Word, Excel, PowerPoint, Visio, etc.).

Your Application

To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our . Further information about Evonik as Employer can be found at .

Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. If you have any questions regarding the application process, please call our Evonik Candidate Support at 0800 2386645 (Germany only) or +49 201 177 4200.

Your Talent Acquisition Manager: Robin Rose

Company is Evonik Canada Inc.

Evonik