Analyst II, QA Validation

Emergent Biosolutions•Winnipeg, MB

About The Position

The Analyst II, QA Validation supports the Validation team by contributing positively and accurately to the completion of all tasks within the related job. Follows standard operating procedures and contributes to the continuous improvement and regulatory compliance within the unit. Makes every effort to complete annual goals established by the department.

Requirements

Attainment of a relevant university degree or technical diploma from a recognized post-secondary educational institution or an acceptable combination of education and experience.
Minimum 2 years functionally related experience preferably in a pharmaceutical manufacturing environment or in a similarly regulated manufacturing environment.
Demonstrated competencies include knowledge of validation principles and practices, strong organizational and interpersonal skills and the ability to work collaboratively with personnel at all levels of the organization.
Must be able to work on multiple projects simultaneously
Basic knowledge in use of Microsoft Office suite of products is required.

Nice To Haves

Possesses Strong knowledge of Project Life Cycle and quality systems, cGMP, and regulatory guidelines and good engineering practices such as ISPE guidelines.
Previous project experience within the pharmaceutical or biopharmaceutical industries is preferred.
Equipment and Systems commissioning and qualification experience up to and including PQ.
Demonstrates success in technical proficiency, and collaboration with others.
Excellent attention to detail, with an ability to work to very tight schedules.
Excellent communication and organisational skills.
Adaptable and flexible.
Ability to pass pre-employment medical and background checks.

Responsibilities

Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc
Write summary reports, following good documentation practices
Use temperature monitoring devices such as the Kaye Validator and/or Ebro dataloggers to perform mapping studies
Write/update SOPs
Analyze statistical data to verify acceptable criteria
Develop testing strategies and rationale for equipment/systems
Provide technical support/troubleshooting for process and equipment issues
Attend production and team meetings, as required
Maintain close contact with manufacturing and laboratory departments to assure effective communication on issues related to validation
Apply cGMP guidelines to all aspects of validation
Investigate/resolve deviations associated with validation studies
Assist with commissioning, FATs, and SATs.
Other tasks as assigned.