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Senior Analytical Laboratory Manager - Pharma
 
  • Degree with 7+ years experience in a pharma GMP environment
  • Experience in analytical development/ analysis of pharmaceutical products
  • Strong communication with experience working with external clients

Kelly Scientific Resources believes in relationships, not transactions. That’s why we’re committed to successfully matching job seekers with the best employers across Canada and around the world.  We fill positions from entry level to senior management, on a temporary or permanent basis. Whether your specialty is Science, Engineering, IT, Finance, Marketing, Manufacturing, Contact Centre or Business Administration, we’ll work with you to understand your likes, dislikes, goals and ambitions, and present you with opportunities that meet your needs. See what we have to offer.

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SENIOR ANALYTICAL LABORATORY MANAGER - PHARMA

Responsibilities:

  • Work with clients directly for day to day laboratory work, negotiated deliverables and complaints
  • Understand client needs and organize lab to ensure expectations are met
  • Implement new programs, tests, methods, instrumentation, and procedures by investigating alternatives
  • Ensure calibration and maintenance is performed.
  • Ensure compliance with current GMP requirements
  • Draft, review and have executed all analytical methods; method validations and method technology transfer studies
  • Review investigation and documentation of all laboratory OOS occurrences
  • Review COAs and approve validation protocols
  • Review and have executed all analytical methods; method validations and method technology transfer studies
  • Write or have written required SOPs and work instructions related to laboratory operation
  • Ensure GMP training is provided
  • Implement CAPA when initiated to include investigation, root cause analysis, corrective and preventative actions and documentation
  • Facilitate internal audits/customer/regulatory audits; and evaluate and implement effective corrective actions
  • Maintain laboratory staff by recruiting, selecting, orienting, and training employees
  • Host GMP audits from clients and regulatory agencies such as Health Canada
  • Oversee supervisors and group leaders such that a strict adherence to a defined hierarchy is maintained
  • Evaluate the abilities and performance of subordinates, mentoring and setting appropriate individual goals

Requirements:

  • B.Sc. or higher with 7+ years’ experience supervising a pharmaceutical laboratory
  • Effective communicator with the ability to lead audits and experience in communicating directly with external clients
  • A strong working knowledge of regulatory requirements
  • A thorough understanding of laboratory safety requirements, MSDS’s and WHMIS
  • A thorough understanding of analytical chemistry and chemical instrumentation, including HPLC, GC, and other common pharmaceutical laboratory instrumentation.
  • Experience with raw material, finished product, and in-process testing, along with method development, validation, and tech transfer 
  • Considerable working knowledge of the methods, materials, and techniques used in laboratory work
  • Ability to manage and schedule the work of others
Job Ref: CA7677BM001443
Submitted: 10-10-2019 07:30 AM
Location: Ontario - Toronto and area
 


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