Investigation Specialist, Production - Candiac, Canada - Pharmascience Inc.

Pharmascience Inc.

Verified Company

Candiac, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 followups 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 followup CAPA actions
Write implement and followup 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