QA Manager Gmp

7 days ago

Dorval, Canada Pathogenia Inc Full time

**Role Description**
- Primarily responsible for the laboratory GMP program
- Maintain and author SOPs, change controls, deviations, and other GMP documents
- Support the preparation and execution of external and internal audits
- Provide technical and GMP training support as required
- Follows all OOS and CAPAs associated with Health Authority inspections, internal audit and self-inspection. program ensuring their timely closure and effectiveness check.
- Manage the equipment qualifications (IQ, OQ, PQ)
- Manage calibration and maintenance of data loggers system
- Maintenance of Quality documentation with Suppliers, Customers, Contractors

**Qualifications**
- Bachelor's or master’s degree in a related field, preferably in microbiology, biochemistry, or pharmaceuticals
- A minimum of 2 years of quality assurance experience with 3 years of supervisory experience in a pharmaceutical or laboratory setting.
- Sound knowledge and experience of laboratory quality systems and Good Manufacturing Practice (GMP) regulations.
- Experience in Root Cause Analysis, CAPA, Change Control, risk assessment, audit experience and compliant handling.
- Experience in implementing critical quality systems related to microbiology testing such as Environmental Monitoring program, Lab equipment calibration and qualification, Aseptic Technique, and Media fill studies
- Strong analytical skills, a logical approach to problem solving, and ability to multitask on simultaneous issues
- Proficient in Microsoft Office (Word, Excel, PowerPoint, and Outlook), Laboratory Information Management System (LIMS) and Quality Management Systems
- A self-starter with the ability to work independently, manage and prioritize tasks and ensure timely completion of the projects
- Effective interpersonal and communication skills to interact professionally with colleagues, staff and the management team
- Demonstrated ability to work effectively in a team
- Excellent communication skills in English and French

**Job Types**: Full-time, Permanent

**Salary**: From $65,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Paid time off
- Vision care

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus pay

Work Location: In person

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