BioVectra Inc. Manager, Quality Operations Full Time in Charlottetown, PE

BioVectra Inc.

Branch Charlottetown PE CA

Manager, Quality Operations
Charlottetown, PE

Manage and trend analytical, production and stability data. Is a leading bio-science business in Prince Edward Island, focused on contract manufacturing and…

BioVectra Inc . is a leading bio-science business in Prince Edward Island, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

BioVectra Inc. has an immediate opening for a Manager, Quality Operations (29 McCarville). This is a permanent, full time position.

The candidate will be responsible for:

  • Perform batch record reviews and make product disposition decisions.
  • Manage and approve all change controls, deviation investigations and Lab Incidents.
  • Manage and trend analytical, production and stability data.
  • Oversight of regulatory actions and recalls related to the product.
  • Preparation, review and approval of controlled documents.
  • Preparation of annual product reviews.
  • Oversight of environmental monitoring programs (air, surface and water testing).
  • Assess gaps in the Quality System and its application, and introduce remediation.
  • Provide quality oversight and guidance ensuring required Quality and compliance standards are met.
  • Build & maintain close communication with the client.
  • Responsible for audit readiness program.
  • Participate in client and regulatory inspections.
  • Travel will be required.

The successful candidate for this position would have:

  • B.Sc. in a scientific discipline.
  • Minimum of 5 years of experience in Quality Assurance working in pharmaceutical and/or biotech.
  • Experience in the design and implementation of quality management systems and continuous improvement.
  • Good knowledge of cGMPs (current GMP), FDA (Food and Drug Administration) and Health Canada pharmaceutical regulations for API’s.
  • Ability to work with minimal supervision in a multi-task team environment.
  • High attention to detail and excellent decision making skills.
  • Excellent oral and written communications skills.
  • Excellent leadership and organizational skills.

BioVectra offers a competitive salary and benefit package. Interested candidates are asked to apply visiting www.biovectra.com

We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.

Job Type: Full-time

Required education:

  • Bachelor’s

Required experience:

  • Pharmaceutical and/or Biotech: 5 years

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Charlottetown, PE, CA
Posted on: 2016-11-01
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