The investigation specialist is the expert for investigations and continuous process improvement initiatives. This person will lead / facilitate investigations related to note to file, deviations and participate to complaint investigations when required.
The investigation specialist will open and participate to the corrective action and preventive actions such as CAPAs. The Investigation specialist will be the expert / SME during audit with client and regulatory agencies.
Initiation of change control when required.
RESPONSABILITIES & DUTIES
- Actively lead and coordinate investigations
- Accountable for timely follow-up and completion of investigation deliverables
- Support and participate investigations as required
- Support documentation of deviation / CAPAs including extensions
- Ensures coaching of all personnel involved in the investigation process
- Adopt the 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, 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
- Perform any other administrative tasks requested by his / her manager
SKILLS, KNOWLEDGE & ABILITIES
- Good understanding of Pharma industry problems (including sterile production as required)
- Good knowledge of continues improvement principles, tools and methods.
- Excellent communication skills (written and oral)
- Must be able to interpret technical documents (e.g. drawings, specification, system manuals)
- 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 lead numerous projects / files at the same time
- Excellent time management and prioritization skills
- Sense of urgency
Spécialiste Investigation - Quart de soir
The investigation specialist is the expert for investigations and continuous process improvement initiatives. This person will lead/facilitate investigations related to note to file, deviations and participate to complaint investigations when required. The investigation specialist will open and part...
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The investigation specialist is the expert for investigations and continuous process improvement initiatives. This person will lead/facilitate investigations related to note to file, deviations and participate to complaint investigations when required. The investigation specialist will open and part...
Spécialiste Investigation
The investigation specialist is the expert for investigations and continuous process improvement initiatives. This person will lead/facilitate investigations related to note to file, deviations and participate to complaint investigations when required. The investigation specialist will open and part...
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