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SalaryAdecco is currently hiring a temporary full-time Engineering Quality Manager in North York, ON. In this role you will support all activities associated with the Commissioning & Qualification of Equipment and Processes associated with the B200 Flu Manufacturing Facility. You will also be responsible for supporting Environmental Monitoring (EM) associated documentation (Strategies, SOPs, Protocols, Raw data review, Reports, etc.)
Apply today to join our team and lead our efforts in maintaining and enhancing quality standards!
Pay Rate: $72.00/hour
Location: North York, ON
Shift: Monday to Friday | 8:00am – 4:00pm
Job type: Temporary | Full-time
Here's why you should apply:
4% vacation paid weekly
Paid weekly accurate and on time
Strong health and safety programs
Medical and dental benefits once qualified
Free training programs
New and quicker onboarding process
Possibility of extension or permanent role
Responsibilities:
You will predominantly support all activities associated with Commissioning & Qualification of Equipment and Process associated with B200 Flu Manufacturing Facility.
You will also be required to review and approve Analytical Instrument Qualification documents associated with various analytical instruments like HPLC, UV/VIS Spectrophotometer, etc.
You will be responsible for reviewing and approving specifications, qualification protocols, data packs and qualification summary reports associated with Facility, Utility and Equipment’s (FUE) and Process (MTech Studies) associated with B200.
You will also apply and interpret cGMP, regulatory requirements, standard, directives and guidelines from Corporate Quality management and regulatory agencies, to ensure records are clearly and appropriately justified.
You will represent Quality Operations in various meetings for the FUE and Mtech Studies and will provide guidance adhering to Global Quality Directives, Pharmaceutical Industry Standards (i.e., GAMP, ICH, ANNEX), Code of Federal Regulations.
You will be responsible to support Environmental Monitoring (EM) associated documentation (Strategies, SOPs, Protocols, Raw data review, Reports, etc.)
You may be required to work flexible hours in order to meet project timelines.
Candidate will be required to be fully fascinated (Flu shot) in order to enter new Building
Qualifications:
Bachelor’s Degree in the field of Science or Engineering
5+ years of experience in a GMP-regulated environment is required
Minimum 5 years’ experience in review and auditing of GMP documentation is required
Strong Quality Mindset
The ability to effectively communicate, both verbally and in written format, through multiple layers of the organization and the ability to think strategically are key to the individual’s success.
Excellent interpersonal and influencing skills and must be able to work in a cross-functional team-based environment
Strong technical background and knowledge in both FDA/EU quality compliance requirements and validation requirements.
Ability to work in a diverse environment and draw upon experience in determining the actions needed to achieve results and remediate issues.
Ability to work in a fast paced environment and make balanced quality decisions.
It would be preferred if the candidate has experience with Document Management Systems (such as QualiPso etc.) applications and trained in Change Management, Nugenesis, Kneat Paperless Validation system etc
Demonstrated ability to meet/exceed timelines/deliverables.
Experience with computerized systems validation, validation of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset.
The individual with experience of supervising third-party manufacturers (for SUS etc) for GMP compliance as with regards to documentation would be an asset.
Must be legally eligible to work, and reside in Canada
Are you interested in this position? Apply now! Our dynamic team of recruiters will reach out if you qualify for this role.
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