Microbiology Supervisor

November 29 2018
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Quality assurance and control - Validation, Microbiology
Kirkland, QC

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Supervisor, Microbiology position to join our growing team! 

What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.
 

Jubilant DraxImage Inc. is a rapidly growing company with offices in Kirkland, QC and Yardley, PA. A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team. Jubilant DraxImage is a proud member of the Jubilant Pharma family. For more information, visit www.draximage.com

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

If you're up for a rewarding challenge, we invite you to take the first step and apply today!

Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive and where our differences are welcomed. By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary

Establishes and maintains Environmental Monitoring (EM) program that meets the internal standards of Jubilant DraxImage (JDI) and those of the regulatory agencies (HPFBI, FDA, EU, etc.).Establishes and maintains microbiological laboratory testing program and provides technical support within the organization which ensures that all manufactured products are tested as per Jubilant DraxImage (JDI) and regulatory agencies standards.

Respnsabilities

  • Plans, schedules, and supervises the testing of finished products, raw materials and stability samples in a timely manner.

  • Plans, schedules, and maintains all environmental monitoring programs to ensure efficient and effective testing of samples from classified clean rooms.

  • Evaluate disinfectant efficacy to ensure that it covers JDI's current microflora.

  • Determine and coordinates the assignment of tasks to be performed by the microbiologists.  

  • Ensures employees are performing to JDI's high standards in the aseptic area (qualified and authorized to access aseptic rooms).

  • Reviews and evaluates unresolved compliance incidents within site operations. Provides scientific expertise and specific recommendations to respective departments.

  • Ensures integrity and accuracy of documents in compliance with GMP. Reviews and approves microbiological and procedural related documents in a timely manner.

  • Investigates out-of-specification (OOS) results and quality incidents within established timeframe and issues reports. Initiate and conduct the investigations for Out-Of-Specifications (OOS) and quality incidents within established timeframe and help in finding root causes.

  • Notifies immediately the Manager of any out of specification, out of trend, or incomplete testing result and other irregularities. 

  • Recommend instruments purchasing/replacement in a cost effective manner that leads to higher quality and efficiency in compliance with cGMP.

  • Recruits and trains analysts to carry out all functions in the microbiology laboratory.  Periodically reviews the performance of analysts with regards to the achievement goals, objectives, and key performance indicators.

  • Performs any other tasks assigned by Management.

Requirements

  • B.Sc, or M.Sc. in microbiology or closely related discipline.

  • Minimum five (5) years of relevant experience in a microbiology laboratory within a pharmaceutical or healthcare environment.

  • Experience within a sterile environment

  • Experience of one (1) years of relevant experience as a Supervisor in a microbiology laboratory within a pharmaceutical or healthcare environment is an asset.

  • Excellent knowledge of environmental monitoring programs and experience.

  • Strong knowledge in microbiology laboratory work and instrumentation.

  • Demonstrated ability to work with changing priorities involving multiple and concurrent projects.

  • In-depth knowledge of cGMP regulations for Canada, USA, EU.

  • Knowledge of microbiology-analytical development, transfer, and method validation.

  • Strong interpersonal, organizational, and communication skills and solid report writing ability.

  • Computer literacy (Microsoft Office and SAP environment).

  • Bilingual (French and English).  Proficiency in English is essential.

Apply now!

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