Operational Quality Specialist

Bora Pharmaceuticals•Mississauga, ON

3d•CA$68,000 - CA$85,000•Hybrid

About The Position

Operational Quality Specialists (OQS) ensure Bora’s products and processes meet established quality standards. They provide quality support to a myriad of areas such as equipment qualification, validation, annual product reviews, deviations, change controls, complaints, Gembas, and batch record review and release. Their key responsibilities are listed but not limited to the following.

Requirements

Experience in Operational Quality Assurance or related role with similar responsibilities; Minimum 2 years in Pharma industry.
Bachelor’s degree in science / engineering / related field or equivalent on-the-job experience through years of service.
Adequate knowledge of regulatory framework and demonstrated ability to make informed decisions.
Demonstrated ability to participate in projects or change initiatives with the ability to make sound quality decisions.
Experience with statistical software, SAP.
Strong interpersonal and communication skills.
Excellent technical report writing and reviewing skills.
Able to work independently and in a team environment.

Nice To Haves

College program completion for OQS role.

Responsibilities

Prepare and implement quality assurance procedures (such as SOPs) and be responsible for reviewing as required.
Participate in investigation of complaints, deviations, and product incidents ensuring that all investigations are thorough, complete, identify root cause, and assign appropriate CAPAs.
Review documentation related to equipment qualification (IQ/OQ/PQ) and process validation, and preparation/review of reports.
Review batch records and associated documentation, releasing or rejecting batches as per quality procedure.
Participate in improvement projects for Quality systems and other special projects and initiatives, including new product introductions, significant changes to equipment/systems, etc.
Coordinate planned changes initiated by various business units, suppliers, as well as customers and ensure relevant quality procedures are followed.
Coordinate responses to internal improvement documents as required, such as audit observations, ensuring compliance to recommendations.
Accountable for team and site metrics.
Participate in inspections including roles such as hosting, mission control, auditor, auditee, etc.