Quality Assurance Associate
3 months ago
**Title**: Associate
**Reports to**: Sr.Manager - Quality Assurance
This position works with the Manager Quality assurance to ensure the compliance for analytical/formulation method development and stability testing activities of Nasal sprays. The role will be focused on data review, GXP compliance of electronic systems and meeting the regulatory requirements.
**Job Function**
**80%**
- Quality Review of Analytical data (HPLC, Malvern Spraytec )
- Empower and other electronic system Audit trail review
- Controlled Substance Area Maintenance
- Review and Release of Calibration and PM documents
- Create and review SOPs
- Perform laboratory audits
- Review of test procedure, specifications and CoAs
- Review and support stability studies execution
- Review and approve quality notifications ;deviations, investigations, change controls
- Act as A/QPIC for controlled substance management
**20%**
- Review and monitor Quality agreements, Device Suppliers, CMOs and GMP documentation from third parties
- Support Vendor qualification activities
- Support 3PL activities
- Review CoAs, Quality notifications, Executed batch documents for batch release of third party manufactured batches
**Key Responsibilities**
- Review and approve laboratory Investigations, Incidents, Deviations and other technical write-ups for QMS notifications
- Track timely completion of QMS notifications
- Perform quality review of the analytical data package of various tests (eg. HPLC testing)
- Review and manage change control activities
- Review and approve equipment qualification
- Review and release calibration standards of instruments such as; weights, pipettes, thermometers, timers, hygrometers etc.
- Coordinate calibration activities of instruments with third party service providers by sending the instrument to them where ever necessary.
- Maintain preventative maintenance and calibration schedule on monthly basis
- Create, review and approve SOPs
- Perform Empower and other electronic system audit trails
- Issue Logbooks/laboratory notebooks and follow up with proper documentation
- Follow up with the training of each personnel and make sure such trainings are up to date
- Follow up with the out of service instruments and related documentation
- Follow up with repair of each out of service instrument and prepare the required documentations
- Perform monthly audit
- Ensuring all the work performed in the laboratories are in GMP compliance
- Review and monitor Quality agreements, Device Suppliers, CMOs and GMP batches
- Review and approval of vendor qualification/service provider documentation
- General activities and administrative
- Any other task that will be assigned by the QA Manager
- Review of Batch manufacturing record
- Support CMO Management activities
**Skills and Qualification**
- BSc in Chemistry and Pharmaceutical Sciences
- Minimum of 4+ years of experience in a pharmaceutical industry
- Minimum of 2+ years’ experience in analytical testing set-up (GMP)
- Knowledge on HPLC testing and familiarity with empower is a must.
- Familiarity with analytical method development in pharmaceutical formulations
- Previous experience in lab as technical data reviewer will be considered as an asset
- Previous experience in Quality control lab will be considered as an asset
- Great attitude and motivated to learn new skills
- Good written and oral communication skills
Pay: $45,000.00-$55,000.00 per year
**Benefits**:
- Extended health care
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Concord, ON L4K4J1: reliably commute or plan to relocate before starting work (required)
Application question(s):
- Please Mention brief experience in Pharmaceutical industry.
**Education**:
- Bachelor's Degree (preferred)
Work Location: In person
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