Investigation Specialist, Production

2 weeks ago

Candiac, Canada Pharmascience Inc. Full time

Proud to be at the forefront of our industry since 1983, Pharmascience is a leader in generic medicines. We’re a Canadian company with global reach that has never lost sight of the human touch. The work environment we’ve chosen to maintain on a day-to-day basis is a stimulating one, based on trust, cooperation and continuous improvement. Join our team

The technical investigation specialist is the focus expert for investigations and production/maintenance process continuous improvement initiatives. This person will lead/facilitate complex investigations related to quality deviations.

**Responsabilities & duties**:

- Participate in quality deviation investigations as a focus expert.
- Coordinate and participate in investigations, ensure follow-ups and support documentation of REQs/CAPAs.
- Ensures coaching of all personnel involved in the investigation process, including use of technical analysis and problem resolution techniques and proper documentation.
- Facilitate root cause analysis sessions for complex investigations that include process focus experts and production/maintenance employees
- Assists to define and implement preventive and corrective measures for identified causes
- Write, implement and follow-up CAPA actions
- Write implement and follow-up CC actions.
- If required, write engineering study protocols
- Contributes to the writing and review of production/maintenance SOPs
- Elaborates and implements tools to assist in continuous improvement initiatives
- Collaborate and coach teams that implement continuous improvement projects
- Perform any other administrative tasks requested by his/her manager

**Skills, knowledge & abilities**:

- Good understanding of Pharma industry problems (including sterile production)
- Good knowledge of continuous improvement principles, tools and methods.
- Excellent communication skills (writen and oral)
- Good knowledge of change management
- Capable of mobilizing people around change
- Excellent knowledge of Word, Excel and PowerPoint software in Windows; SAP (asset)
- Autonomy, initiative and resourcefulness
- Able to work tactfully and diplomatically with people at all levels
- Able to set goals and work on numerous projects/files at the same time
- Sense of urgency

**Experience**: Required
- Knowledge of operation principles of equipment and systems used for pharmaceutical production (ex: autoclaves, lyophilizers, ovens, WFI/PW/Steam/HVAC/Compressed air systems; etc).
- Completion of courses in proper documentation practices
- Knowledge of sterilization, filling and packaging processes (asset)
- Trained in aseptic techniques and documentation pertaining to aseptically filled products (asset).
- 3 year(s): Years in similar position

**Education**: Preferred
- Bachelor or better in Science or related field

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