Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
Job Description
Description Title: Specialist - Quality Assurance - Operations - Permanent
1. Position Summary
Reporting to the Team Leader Quality Assurance - Operations:
Ensures quality and compliance objective for plant activities and operations are respected.
Acts with the highest standard of rigor during the execution of their tasks respecting the procedures for which they are responsible.
Ensures compliance with standard operating procedures for all plant sectors.
2. Tasks
- Verifies the batch records of the plant and CMOs
- Ensures the release of finished products raw materials and packaging components.
- Monitors quality events from creation to resolution by liaising with experts from various areas of the plant and CMOs
- Ensures that corrective and preventive actions are defined and carries out the final disposition of the event.
- Participates in the implementation of internal procedures specific to the departments activities.
- Participates in the implementation of the GMP training program for new employees.
- Provides quality support within the production/installation and planning departments.
- Applies health and safety policies on a daily basis raises health and safety issues and proposes improvements to various problems.
- Participates in the continuous processes improvement in a LEAN company.
3. Main Professional Relations:
- Provides a quality advisory role to the production and engineering department with respect to good manufacturing practices
- Strong communication skills and the ability to interact with all plant services and CMOs
4. Knowledge and Skills Required:
a) Training Required
- Bachelors or Masters Degree in Chemistry Pharmacy or Biological Sciences or has equivalent experience combined with a collegial diploma in similarly related science.
b) Languages
- Excellent communication skills in French and English both in written and spoken.
c) Specific Experience and Knowledge
- Minimum 5 years experience in the pharmaceutical industry
- Minimum 3 years experience in a Quality Assurance in a similar position
d) Specific Technical Skills:
- Proven knowledge of Canadian US and International GMP regulations.
- Knowledge of pharmaceutical production processes
- Excellent organizational skills and dealing with priority management.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.
Required Experience:
IC
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and valu...
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
Job Description
Description Title: Specialist - Quality Assurance - Operations - Permanent
1. Position Summary
Reporting to the Team Leader Quality Assurance - Operations:
Ensures quality and compliance objective for plant activities and operations are respected.
Acts with the highest standard of rigor during the execution of their tasks respecting the procedures for which they are responsible.
Ensures compliance with standard operating procedures for all plant sectors.
2. Tasks
- Verifies the batch records of the plant and CMOs
- Ensures the release of finished products raw materials and packaging components.
- Monitors quality events from creation to resolution by liaising with experts from various areas of the plant and CMOs
- Ensures that corrective and preventive actions are defined and carries out the final disposition of the event.
- Participates in the implementation of internal procedures specific to the departments activities.
- Participates in the implementation of the GMP training program for new employees.
- Provides quality support within the production/installation and planning departments.
- Applies health and safety policies on a daily basis raises health and safety issues and proposes improvements to various problems.
- Participates in the continuous processes improvement in a LEAN company.
3. Main Professional Relations:
- Provides a quality advisory role to the production and engineering department with respect to good manufacturing practices
- Strong communication skills and the ability to interact with all plant services and CMOs
4. Knowledge and Skills Required:
a) Training Required
- Bachelors or Masters Degree in Chemistry Pharmacy or Biological Sciences or has equivalent experience combined with a collegial diploma in similarly related science.
b) Languages
- Excellent communication skills in French and English both in written and spoken.
c) Specific Experience and Knowledge
- Minimum 5 years experience in the pharmaceutical industry
- Minimum 3 years experience in a Quality Assurance in a similar position
d) Specific Technical Skills:
- Proven knowledge of Canadian US and International GMP regulations.
- Knowledge of pharmaceutical production processes
- Excellent organizational skills and dealing with priority management.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.
Required Experience:
IC
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