Batch Records Manager

North York - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

We’re hiring a Batch Records Manager for our client, a large pharmaceutical company, to join their team. This is a one-year contract.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities

  • Provide standardization and optimization of our production methods (master Batch Production Records/ mBPRs) across the site. Provide guidance in the structure and content of mBPRs. In addition, support the continuous improvement initiatives across the site by creating and/or updating effective and compliant master BPRs in a timely manner.
  • Create and update mBPRs (design/re-design mBPRs in a consistent manner, ensure the technical components of the mBPRs conform to manufacturing procedures, master specifications, and GxP requirements. The results should be mBPRs that are efficient, effective and compliant)
  • Optimize and standardize mBPRs (seek opportunities to improve our recording of manufacturing data and apply these improvements to new mBPRs or during the maintenance/updating of existing ones, create and maintain the database of standard objects)
  • Support continuous improvement initiatives within manufacturing (support new initiatives and/or manufacturing facilities by providing guidance in data recording requirements, drive standardization of manufacturing methods across similar processes, coordinate and facilitate discussions in the development of mBPRs with all stake holders)
  • Maintain the mBPR and associated supplement/form printing packages in the BPR management system
  • Write and maintain policy documents
  • Training (prepare training procedures, train and certify staff on the use of Regulus and/or Compliance Suite systems) Participate in validation activities for BPR management systems upgrades, as applicable

About you

Requirements

  • 4 – 6 years experience and understanding of manufacturing/testing environments in the pharmaceutical Biotech Industry
  • Experience with GxP computerized systems is an asset Systems validation experience within GxP systems (nice to have)
  • Strong Documentation Skills - understanding of the lifecycle of a document GxP experience is a must - this experience should ideally be in a manufacturing environment but not required
  • Experience with developing training material and delivering training to internal customers
  • Knowledge and competencies in project management principles
  • Good problem solving skills to overcome project constraints /risks
  • Excellent communication and negotiation skills for customer consultation, input and interaction with regulatory inspection teams and senior management
  • The ability to manage/handle multiple projects and respect timelines
  • Work as a team, creativity, work with time constraints for completion of deliverables as per schedule and be able to quickly respond to changing priorities.
  • A minimum of a B.Sc degree in Life Science-related field (e.g. Biology, Biochemistry, Biotechnology, Pharmacology, Chemical Engineering and Health Science).

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB223501
  • Location: North York
  • Market: Life Sciences & Health Care
  • Hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of expertise: Regulatory
  • Closing date: Monday, September 9, 2019
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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