Quality Assurance Associate
Zany Consulting Group - Toronto, ON
Build a better career with Zany Consulting Group
Serving customers and community starts with the most talented people doing their very best work. That is precisely what we have at Zany Consulting Group, a leading Professional Services Consulting firm.
Zany Consulting Group is seeking exceptionally driven, experienced Documentation Specialist to undertake projects for one of our clients in Toronto.
In this role :
The successful candidate will be responsible for investigating all major, critical and recurring deviations associated within the Platform and Collaborating with Quality Operations (QO), Subject Matter Experts (SME) and Lead Investigators (LI) from other departments as required and determine the scope of the investigation.
Develop an investigation strategy in collaboration with Production, Quality Operations, SMEs.
Select appropriate analytical tools, conduct process walks, collect and analyze data to determine root cause.
Identify expertise required for the investigation (QC, QOVS, QOSA, MTech, Technical Services).
Identify, co-ordinate and manage contributions from other departments.
Participate in Focus Factory Support teams for planning and execution of investigations.
Review and provide guidance on reports prepared by technical staff.
Support manufacturing investigations associated with OOS / OOTs, Utility Interruptions, Environmental Monitoring excursions, Complaints.
Support investigations of minor non-conformances and development of templates as required.
Develop and present risk assessments
Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages.
Develop appropriate corrective and preventive actions in collaboration with platform management and other stakeholders, develop appropriate CAPAs to address the root cause.
Work with Platform Leaders to identify and develop process improvements to remediate risks, improve investigations and avoid future deviations.
Skills & Qualifications
Bachelors' degree in the field of science from a recognized institution
Post-graduation in Microbiology, Biochemistry or related field would be preferred.
Four (4) years of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role.
High level of knowledge of cGMPs in pharmaceuticals / biological manufacturing environment
Experience in regulatory inspections
Excellent technical writing skills
Six-sigma or other root cause training and experience
Knowledge and experience with multiple software programs such as SAP, Track wise, Word, Outlook, Visio and PowerPoint
Additional Skills : Audits
Zany Consulting Group strives to help our customers achieve greater productivity, profitability, and quality work through a team of experienced consultants in the pharmaceutical industry.
When you join our team, you will receive rewards and recognition for your contributions, training and professional development opportunities.
If you are inspired to learn, take risks, and succeed as a team, you can build a better career at Zany Consulting Group.
Equal Opportunity Statement : All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity.
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