Industrial Chemist - Quality Assurance Compliance Specialist

July 31 2019
Industries Pharmaceutical, Biotechnology
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Chemical, Manufacturing - Production - Industrial, Quality assurance and control - Validation, Chemistry
Saint-Laurent, QC

$ 60,000.00 to $ 80,000.00 / year (To be negotiated)

1 vacant position

Fixed term or contract, Full time 40 hours / week

Beginning date: 2019-07-01

End date: 2021-06-30

Benefits: Disability Benefits, Medical Benefits, Dental Benefits, Group Insurance Benefits, Pension Plan Benefits, RRSP Benefits

Terms of Employment: Overtime, Morning, Day, Weekend, Flexible Hours

Job requirements

Languages: English or French

Education: Bachelor's degree

Field of study: Biology / Biological sciences (general)

Experience: 5 years or more

Other Skills: Good Manufacturing Practices

Field of Work Experience: Assurance or Quality Control

Process and Industrial Products Experience: Quality Assurance and Quality Control

Work environment: Pharmaceutical industry

Detailed Job Description

- Reviews, in a timely manner, all qualification/validation documents (IQOQPQ, CV, PV, Calibration, Preventive Maintenance, etc.), analytical method validation documents and master batch records ensuring that they meet current GMP regulations

- Reviews and approves incident (deviation)/investigation reports and non-conformance (OOS) investigations

- Performs internal and external audits, as scheduled and assigned

- Conducts investigations, as required, ensures the event is well-described, identifies the potential quality impact, determines the root cause and corrective actions to minimize future events

- Ensure GCBT activities comply to the applicable current GMP regulations and GCBT SOPs

- Performs risk assessments (for example, FMEA), as needed, and assists in determining preventive actions to prevent issues from occurring, for continual improvement initiatives, etc.

- Reviews and approves change requests related to quality, production, facility and utility systems/activities

- Writes/revises, reviews and/or approves SOPs/Working Instructions/Forms (QA and/or other departments)

- Tracks and trends key quality performance indicators and conducts appropriate follow-ups as required

- Provides cross departmental support to quality control, production, validation, engineering, etc.

- Provides training for GMP procedures and processes, as needed

- Ensures the integrity and traceability of all data generated and reported

- Performs other duties as assigned by Quality Lead

How to apply

By email: *******@************.***

Target audience of the job offer

Anyone legally authorized to work in Canada can apply for this job. If you are not currently authorized to work in Canada, the employer will not consider your application.

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