Quality Assurance Associate

4 days ago

Concord, Canada Rubicon Research Full time

**Job Function**
- Maintain equipment and instrument collaboration schedule
- Perform preventative maintained, mapping, calibration and qualification of laboratory equipment
- Review calibration records and standards
- Create and review SOPs
- Perform laboratory audits
- Review and monitor Quality agreements, Device Suppliers, CMOs and GMP documentation from third parties

**Key Responsibilities**
- Perform preventive maintenance, mapping, calibration and qualification of laboratory equipment such as stability chambers, fridge, freezer and instruments that need to be calibrated and mapped
- Review calibration standards of instruments such as; weights, pipettes, temperatures, thermometers, timers, hygrometers, FloCat Volumetric Differential Pressure Meter, ACI (A) cascade, etc., send the instruments for calibration based on the calibration requirements
- Review calibration record of each instrument and update the calibration/qualification records as necessary
- Create and prepare SOPs and protocols, review drafted SOPs and implement the procedures
- Issue CRRs/Logbooks/laboratory notebooks and follow up with proper documentation
- Assess functionality, performance, reliability, stability of each instrument
- 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
- Review the after-repair documentation make sure all necessary data are in place before releasing the instrument
- Review IQ/OQ/PQ data and make sure that the data is accurate
- Perform monthly audit
- Ensuring all the work performed in the laboratories are GMP compliance
- Review and monitor Quality agreements, Device Suppliers, CMOs and GMP batches
- Review and approval of vendor qualification/service provider documentation
- Laboratory Investigation, Incidents, Deviations, and QMS
- Vendor audit and qualification
- General activities and administrative
- Another important task that will be assigned by the QA Manager
- Review of Batch manufacturing record
- Follow up with the deviations related to CMO batch manufacturing record
- Make sure proper CAPA is in place on CMO manufacturing site

**Skills and Qualification**
- BSc in Chemistry and Pharmaceutical Sciences
- 5+ years of experience in a development laboratory and/or CMO setting
- Understanding od ISO 17025:2017, ICH guidelines
- Great attitude and motivated to learn new skills
- Good written and oral communication skills

**Salary**: $50,000.00-$60,000.00 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)

**Speak with the employer**

+91 8219333489

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