CQV Specialist

CQV Specialist
Pharmaceutical Manufacturing
North York, ON

Responsibilities:
 
1. Be part of the Commissioning, Qualification & Validation (CQV) team of a large new bulk vaccine manufacturing facility.
2. Deliver a set of Design Qualifications (DQs) and Factory Acceptance Tests (FATs) in a timely manner. This includes:
a. Planning protocol preparation and/or report, review and approval
b. Execution of approved protocols
c. Review of executed results and closure of data packages
d. Ensuring all punch list items are closed, if not transferred to Fieldwire
3. Timely compilation, review and approval of Vendor and Construction Turnover Documentation (V/CTOD) packages
4. Pre- and post-review and approve all commissioning related testing documentation of non-GxP systems.
5. Closely coordinate with the Construction Management Company to:
a. Ensure construction related documentation and testing strictly follows established quality procedures/practices and approved protocols
b. Coordinate and facilitate the executions of Installation Verifications
6. Support all CQ Methods related activities such as:
a. Issuing and updating Project Specific Procedures (PSPs)
b. CQ phase document (such as trace matrix and commissioning protocols) development and review
c. Change control and deviation management processes
d. Non-product dependent Performance Qualification activates
e. Support Function and Component Criticality Assessments
7. Lead the timely compilation, review and approval of Engineering Turnover Packages
8. Accountable for ensuring all applicable safety procurers and practices are followed by all members of the CQ Methods team
9. Other CQV related activates as needed.
 
Required Education & Experience:
 
1. Degree in Science or Engineering
2. 5+ years’ hands-on/field experience in commissioning and qualification of pharmaceutical facilities
3. Demonstrated experience in coordinating project activities.
4. Demonstrated ability to work as a team member, and in a fast paced environment.
5. Strong interpersonal skills.
6. Excellent problem solving and troubleshooting abilities.
7. High level of familiarity with Excel, Word, and Microsoft Project, required.
8. Proven organizational, time management, and project management skills.
9. Excellent oral and written communication skills.