Ensure compliance with quality standards in manufacturing, manage deviations and investigations, and participate in quality audits to uphold product quality.
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
#LI-PFE
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role, you will:
- Ensure the application of established quality systems to meet Pfizer and regulatory authority requirements for on-site finished product manufacturing.
- Ensure that GMP standards, as applicable to each specific product, are consistently met and that the site remains in full compliance with Pfizer and regulatory expectations.
- Manage, investigate, review and follow on site quality deviation report's approval
- Review laboratory investigation reports
- Address customer complaints
- Follow on external deviation such as temperature excursions of imported materials or exported products
- Monitor and review CAPAs and commitments resulting from investigations
- Create, update, and approve QA-controlled documents
- Prepare, follow up and communicate monthly quality performance metrics
- Organize, prepare and partipate in monthly SQRT (Site Quality Review Team) meetings
- Participate in internal and external audits
- Contribute in NTM - Notification to Management process
- Prepare and review AQRT (Area Quality Review Team) reports following NTM
Here Is What You Need (Minimum Requirements)
- Bachelor's + 5 or Degree in Pharmacy, Biology, Chemistry, or equivalent field
- Experience in pharmaceutical industry / quality assurance or a similar regulated environment
- Strong knowledge of GMP, regulatory compliance, and quality systems
- Excellent analytical, organizational, and communication skills
- Fluent English and French
Bonus Points If You Have (Preferred Requirements)
- Experience at a manufacturing site
- Managing and writing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
- Strong problem-solving skills
- Ability to work independently and as part of a team
- Excellent time management and multitasking abilities
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
#LI-PFE
Top Skills
Enterprise Resource Planning
Gmp
Quality Systems
Regulatory Compliance
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