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Manager, Quality Control

3 months ago

Boucherville, Quebec, Canada Delpharm Boucherville Canada inc. Full time

The QC Manager manages chemical and physical testing in 2 laboratories (raw material and finished product/ FUST stability) and the activities of the SIME group.


The QC manager also has the responsibility for the testing in external laboratory to ensure that their activities are compliant with internal requirement.


Responsibilities:

  • Provide Leadership to the 5 QC supervisors, 3 specialists and their teams (57 persons) by setting SMART objectives and achieving key performance and quality indicator targets for each subgroup;
  • Support and coach QC supervisors to effectively manage the personal in order to deliver the performance with quality laboratory work;
  • Nurture and sustain a culture which fosters learning, continuous improvement, recognition and talent development within the organization;
  • Establish a process of capacity versus workload planning to ensure the ontime delivery to meet the compliance and site cycle time targets;
  • To work within the QC supervisors, responsible for overseeing lab investigations (internal and external laboratories) in support of commercial drug manufacture;
  • Evaluate, select and establish business relationship with key subcontract lab partners: review service agreement, compare financial cost of the testing fees, evaluate lab investigation compliance level and track turnaround time;
  • Participate to negotiation of contract with external laboratory;
  • Provide leadership and support to the initiatives of "safety based behaviors" in the laboratory activities.

Requirement:

  • B.SC Chemistry or related field with Ordre des Chimiste accreditation;
  • Relevant work experience required :58 years;
  • Technical knowledges (Analytical methods, GMP, Equipment, etc.)
  • Demonstrated experience with regulatory agencies including Health Canada, FDA, EMA and other Health Authority agencies;
  • Strong understanding and appreciation for process improvement methodologies (e.g. Six Sigma, Lean Manufacturing).
  • Bilingual french and english;
  • MsOffice and SAP.