Supervisor Ii, Em

1 week ago

Montreal, Quebec, Canada Jubilant HollisterStier General Partnership Full time

Supervisor II, Environmental Monitoring

Purpose of the Job:


Establishes and maintains Environmental Monitoring (EM) programs of Jubilant' sites that meet the internal standards of Jubilant Pharma and those of the regulatory agencies (HPFBI, FDA, EU, etc.).


Key Accountabilities:

  • Plans, schedules, and maintains all environmental monitoring programs to ensure efficient and effective testing of samples from classified clean rooms. Determine and coordinates the assignment of tasks to be performed by the analysts (including sampling in the aseptic area). Ensures analysts are performing to high standard in the aseptic area (qualified and authorized to access aseptic rooms).
  • Recruits and coordinates training of the analysts to carry out all functions of the Environmental Monitoring (EM) program.
  • Plans, prepares and leads the Environmental Monitoring Reviewing Board to present the EM data and trends and to followup on corrective actions and/or tasks (when applicable).
  • Reviews and evaluates unresolved compliance incidents within site operations. Provides scientific expertise and specific recommendations to respective departments.
  • Initiate and conduct the investigations for Out-OfSpecifications (OOS) and quality incidents within established timeframe.
  • Maintains legible and complete records of all analytical results, instrument readings, and observation. Ensures integrity and traceability of all data generated and makes all necessary corrections in accordance with GMP requirements and Jubilant Pharma standards.
  • Recommends instruments purchasing/replacement in a cost effective manner that leads to higher quality and efficiency in compliance with cGMP.
  • Notifies immediately the Manager, Microbiology of any outofspecification, outoftrend, or incomplete testing result, and other irregularities.
  • Periodically reviews the performance of analysts with regards to the achievement goals, objectives, and key performance indicators.
  • Performs any other tasks assigned by Management

Education and Experience:

  • B.Sc. in Microbiology or closely related discipline.
  • Minimum five (5) to ten (10) years of relevant experience in a microbiology laboratory preferably within Quality Control. Experience of at least three (3) years of relevant experience as a Supervisor (or similar) in a microbiology laboratory within a pharmaceutical or healthcare environment is an asset.
  • Broad experience with Mobile Data Acquisition (MODA) system or similar
  • Indepth knowledge of cGMP regulations for Canada, USA, EU.
  • Computer literacy (Microsoft Office and SAP environment, Electronic Data Acquisition System).
  • Bilingual (French and English). Proficiency in English is essential.
  • Demonstrated ability to work with changing priorities involving multiple and concurrent projects.
  • Excellent analytical skills.

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