Manager, Quality Control, Compliance & Document Review

OPTALENT | CANADA
Posted on 12 December 2021

Information

Industry Manufacturing
City Brampton East
Code postal L6T 1C1
State Ontario
Required experience
Salary $75,000 - $95,000

Description

Our client, a leader in the pharmaceutical industry is looking for a Manager of Quality Control, Compliance & Document Review to join their operations.

Job Purpose:

  • Audit readiness and compliance of the QC Finished Goods, Raw Material, Microbiology and Development laboratories to SOP’s and GMP requirements.
  • Manage the QC software and software data in conjunction with IT and site QA to ensure the data integrity of the software, especially Empower and LIMS.
  • Manage the QC review team to ensure that the all the QC laboratories are in compliance with cGMP and meet all the
    approved procedures.
  • Manage the LIMS team to ensure that all processes in LIMS meet the compliance requirements and provide efficiency
    within the QC department. Work with partners in Israel to ensure that the LIMS processes between the sites align for compliance.
  • Host and perform audits for the QC laboratories, ensuring that the labs are audit ready, being the subject matter
    expert in regards to data integrity.

Principal Duties and Responsibilities :

  • Manage personnel including regular feedback and performance reviews.
  • Ensure that all laboratory related documents for incoming goods, raw material, bulk, finished products, and stability are reviewed to meet cGMP requirements prior to release.
  • Ensure that the QC development documents for development, remediation and validation of analytical methods meet the cGMP requirements prior to approval.
  • Ensure that the software in use at the facility (i.e. LIMS and Empower plus the stand alone equipment) meets the data integrity requirements through the software validation or processes that are in place in the laboratories.
  • Create, review and write SOPs pertaining to the QC laboratories, with a focus on ensuring data integrity.
  • Review current systems and procedures and implement changes where appropriate to improve accuracy and throughput. Continue to update through continuous improvement processes and procedures for review and compliance.
  • Review out-of-spec investigations to ensure adequate conclusions
  • Complete all GMP Documentation correctly and in a timely manner
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • As the QC SME, host, perform and participate in Internal, Customer and Regulatory Audits.
  • Aid the QA department in performing audits of contract laboratories, vendors and standard vendors for the QC laboratory.
  • Review and approve specifications, C of A’s and documents for submission, product launch through LIMS and other procedures.
  • Ensure that the monthly reports are be sent on time and ensure mitigation/remediation of gaps identified
  • Act as back up to the QC Director for approval of specifications, C of A’s, reports and other documentation as required.
  • Responsible for overall day-to-day operation of the department and back up to provide support to other QC
  • Mangers in the QC Managers absence.
  • Other duties as assigned

Knowledge, Skills and Abilities

  • Minimum of B.Sc. Chemistry
  • 7-10 years’ experience at the management level in a pharmaceutical quality control lab
  • Recognized as a positive leader and change agent
  • Experience with paperless LIMS systems, Empower and major stand-alone software systems
  • Prefer experience with creams, ointments and liquid drug products.
  • Experienced Management capabilities.
  • Solid understanding of laboratory systems following cGMP requirements.
  • Solid investigative techniques to determine “ root cause “
  • Experienced in pharmaceutical environment
  • Excellent Knowledgeable in computerized systems supporting labs operations, in regards to LIMS, Empower and small instrument software.
  • Extensive knowledge of pharmaceutical operations and laboratory support
  • Extensive knowledge of cGMP, GLP, FDA, TPP, HPLC, wet chemistry
  • Knowledge of pharmaceutical standards
  • Excellent organizational skills and ability to multi-task
  • Excellent communication skills (written and verbal skills) and interpersonal skills
  • Thorough knowledge of cGMP, GLP, FDA, TPP, HPLC, wet chemistry and/or microbiology functions
  • Thorough knowledge of current laboratory technology
  • Knowledge of validation (method, process and cleaning)
  • Knowledge of BPCS
  • Knowledge of applicable software
  • Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
  • Excellent written communication and report writing skills
  • Strong organizational skills and ability to multi-task; detail oriented

Contact us now

for an assessment of your needs

1 866 798-9992
[email protected]

Montréal

Québec

Toronto


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