Pharmascience
Job title:
Senior Investigation Specialist
Company
Pharmascience
Job description
Description :Do you want to put your expertise to work for the greatest number of people? Do you want to make a difference by harnessing your talent in the service of human health? A healthier world starts with you! You’re the vital link between our drugs and our patients. Choosing Pharmascience is also about choosing you, because human health—including your own—is at the heart of our mission, and your personal and professional growth is of the utmost importance to us. Being able to grow is what working with a leading Canadian generic pharmaceuticals company is all about.Benefits of working at Pharmascience:
- Annual bonus
- Internal referral program of up to $3,000
- Vacation and floating vacations upon hiring
- Group insurance coverage as of day 1, including telemedicine
- Competitive pension plan with employer contribution as of day 1
- Employee assistance program
- Ongoing training offered
- Stimulating and collaborative work environment
- On-site parking
- Gym
The senior investigation specialist is the expert for complex investigations and continuous process improvement initiatives. This person will coach newly hired investigation specialists and lead/facilitate complex investigations related to note to file, deviations and participate to complaint investigations when required. The senior investigation specialist will write risk assessments for identified compliance hot topics and will open and participate to the corrective action and preventive actions such as CAPAs. The senior Investigation specialist will be the expert / SME during audit with client and regulatory agencies. Initiation of change control when required.Responsibilities:
- Participate and lead complex investigations
- Coordinate complex investigations, ensure follow-ups and support documentation of deviation/CAPAs including extensions.
- Ensures coaching of newly hired investigation specialists and 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 employees
- Assists to define and implement preventive and corrective measures for identified causes
- Write risk assessments for identified compliance hot topics and write, implement and follow-up CAPA actions
- If required, write protocols
- Contributes to the writing and review of production SOPs
- Elaborates and implements tools to assist in continues improvement initiatives
- Collaborate and coach teams that implement continues improvement projects
- If required, is assigned as super-user or administrator of systems or equipment
- If required, participate in continuous improvement committees.
- Perform any other administrative tasks requested by his/her manager
Skills, Knowledge and Abilities:
- Good understanding of Pharma industry problems (including sterile production)
- Good knowledge of continues 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
- High Sense of urgency
- Trained in aseptic techniques and documentation pertaining to aseptically filled products
- Knowledge of sterilization, filling and packaging processes
- Completion of courses in proper documentation practices
Education : BachelorExperience : 5 years: Experience in a similar role
Expected salary
Location
Canada
Job date
Tue, 11 Jun 2024 23:32:20 GMT
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