Vita Health Products Inc. TERM Senior Quality Assurance Analyst (pharmaceutical) Temporary in Winnipeg, MB

Overview

Vita Health Products Inc.

Branch Winnipeg MB CA

Position:
TERM Senior Quality Assurance Analyst (pharmaceutical)
Location:
Winnipeg, MB

Minimum 10 years of experience in quality assurance auditing, certification, and SOP review & development. If you have over 10 years in quality assurance, have…

Due to a high increase in work load; our Quality Assurance team is looking for a six (6) to twelve (12) month Term Senior Quality Assurance Analyst to join their group immediately. This is not open for consultation but for full time term employees or consultants open to converting during this term.

If you have over 10 years in quality assurance, have established and defined Training on Proper Investigation Report Writing, Structure & new SOP’s development, performed quality reviews and editing, and have provided audit support in the past we would love to talk!

What you will do:

• Define Training on Proper Investigation Report Writing & Structure & new SOP
• Define Metrics, Trend analysis report & Schedule Frequency
• Refine SOP for CAPA to better define what goes into a CAPA and when to trigger one
• Redraft SOPs for PNCR’s/SNCR’s and work towards only 1 Deviation System
• Redraft SOP for SORs to streamline workflow i.e non GMP changes flow to dept head for closeout
• Define SOP for actual CCR construction (not how to use the tool, how to write and provide evidence for closure)
• Define Metrics and System to identify and close out overdue tasks and Report into Quality Scorecard
• Review and follow up on all batch related NCR and/or SORs.
• Ensures the batch release criteria have been met and all required documentation enclosed.
• Ensures all deviation reports are adequately resolved and that all required signatures are obtained.
• Initiates Change controls, SORs, and/or NCR’s as required
• Coordination of release documentation (C of P’s, C of M’s) with customers.
• Updates and creates Standard Operating Procedures to align with current practice
• Responsibilities include: hosting opening and closing meetings with auditees, auditing, writing audit report-including audit citations, audit closure, follow-up/ track until all citations have been closed

Qualifications:

• Experience in a QC environment in Pharma/Biopharma is mandatory
• Sc. or College diploma
• Trained in GMP (General Manufacturing Practices)
• Minimum 10 years of experience in quality assurance auditing, certification, and SOP review & development
• Preference may be given to candidates with an auditing certificate from ASQ, ISO, or ISPE

Due to strict deadlines; this position offers a competitive package and may qualify for term accommodations, along with flights home every 3rd weekend.
If you are curious about this opportunity and would love to learn more before applying; don’t hesitate to contact Darlene Mager; Recruitment Specialist at Vita Health Products Inc. in the strictest of confidence at204-470-6090or submit your resume directly for consideration.

Vita Health offers opportunity for advancement, competitive compensation, a strong social committee and involvement supporting the community. With over 220,000 square feet of manufacturing, packaging and distribution in our Winnipeg facility, Vita Health is the leading supplier of over-the-counter (OTC) pharmaceutical products and natural health products to the store brand industry. We also have a significant and growing business in Branded natural health products and sports nutrition – to learn more visit www.vitahealth.ca!

Job Type: Temporary

Required experience:

• Must have significant experience with the audit and regulatory processes with pharmaceutical: 8 years