Quality Assurance Engineer- Pharmaceutical

Our multinational pharmaceutical client is looking for a Quality Validation Specialist to join the team. He/She will be responsible for providing expertise and guidance with regards to regulatory requirements for computerized systems validation and overseeing quality practices. He/She will participate, lead, and or execute validation strategies as well as providing support for the quality processes and procedures. He/She will review and approve validation documentation in accordance with internal and regulatory policies.

This is a full time, 1-year contract opportunity with a potential for extension, located in North York.

Responsibilities

* Provide expertise and guidance with regards to regulatory requirements for validation of site manufacturing shop floor and QC computerized systems and quality practices.

* Provides decisions, guidance, and recommendations pertaining to computerized systems, strategies, procedures, and validation activities.

* Provide interpretations of regulatory guidelines and regulations for validation of computerized systems across full system life cycle from requirements to decommissioning.

* Participates, leads, and or executes validation strategies as well as providing support for the quality processes and procedures.

* Support validation of site computerized systems, and provide validation expertise and guidance to project teams for computerized systems using a risk-based approach along with the project and system life cycle.

* Support operation & maintenance phase of computerized systems to ensure computerized systems are maintained in a validated state.

Qualifications

* Degree in Engineering / Science combined with 5 to 7 years of relevant working experience within the biopharmaceutical industry.

* Strong communication, interpersonal skills, and teamwork are a must, as individuals will be working on cross-functional project teams which include members from various organizations such as Bulk-manufacturing, Engineering, and QC Labs.

* Good interpersonal and influencing skills are important for success in this role

• * In-depth knowledge of the principle discipline - validation and biopharmaceutical industry compliance, i.e. cGxPs, current industry standards, and practices.