Manufacturing Quality Assurance (MQA) Specialist

Accepting BioReady™: Yes
Category: Quality Control / Assurance
Education: Bachelor
Salary:
Location: Mississauga, ON
Posted: October 9, 2019
Closes: November 9, 2019

Job description:

Weekend Shift hours: 8:00 AM- 4:30 PM- Saturday, Sunday, Monday, Tuesday, Wednesday

Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services for the client, development, manufacture, purification, and packaging of therapeutic proteins.

The position is accountable to address QA activities as assigned by the Supervisor, Manufacturing Quality Assurance relating to clinical and commercial manufacturing, and related issues which directly or indirectly impact product quality. Areas of responsibility include QA oversight of GMP areas, batch record review, investigations, and product disposition. Responsible for ensuring GMP compliance in line with USFDA, Health Canada, EU requirements, and other regulatory bodies and standards.

MAJOR RESPONSIBILITIES:

Production Support

  • Present in the Manufacturing and Fill Finish areas and provide on the floor support to production and perform Aseptic Filling / Manufacturing surveillance and Quality Oversight of GMP activities as required by approved procedures.
  • Perform checks or audits on production activities to ensure all work is performed in full compliance with GMP, SOP and related regulatory requirements.
  • Perform immediate assessment of impact and criticality of all events and make decision to continue or stop production activities.
  • Assist Validation group and provide Media fill support.
  • Perform real-time batch record review on the floor as process is occurring.
  • Perform Room Release / Change-Over Approval / Line Clearance as required by production in a timely manner.
  • Perform Visual inspectors’ qualification and AQL Inspection as per approved procedures.
  • Verify batch documents prior to issuance to Production.
  • Attend Batch Readiness and Scheduling Meetings.

Investigation Support

  • Assist Compliance Coordinators with the investigation of deviations/non-conformances by providing guidance and support to in root cause determination and reviewing the impact and criticality of the event with respect to product function, quality, effectiveness, safety, reliability and customer satisfaction.
  • Evaluate the appropriateness of the CAPA identified to address the root cause of the issue.
  • Perform Quality and Compliance impact assessment of the event on products and processes.
  • Review investigations for thoroughness and completeness and approve investigation reports in Trackwise or on paper.
  • Perform trending of incidents and prepare monthly report for presentation to Senior Management during Quality Metrics/Quality Council Meetings.

Batch Review and Product Disposition

  • Review and approve Master Batch Documents (Batch Production Records (BPR), Buffer/Solution forms, and other documentation associated to batch manufacturing).
  • Review executed batch records (BPR, Buffer/Solution forms, and other documentation associated to batch manufacturing), including equipment print outs, temperature charts, etc.
  • Proactively perform follow up on outstanding issues to ensure timely batch disposition.
  • Effectively disposition (release or reject) a batch ensuring compliance with regulatory and internal requirements.
  • Generate and approve Therapure Biopharma Inc. Certificate Of Compliance.

Other Activities

  • Perform deviation/non-conformance investigations, as required.
  • Interface with client, as required.
  • Collaborate and effectively communicate with internal customers, as necessary, to provide required documentation and/or
  • resolve documentation or compliance issues.
  • Assist with the GMP and procedural training program for department’s new hires and current employees as required.
  • Address gaps and perform revisions to departmental SOPs, forms and processes to streamline systems and ensure compliance to GMP, GXP and related company and regulatory requirements.
  • Provide proactive leadership in moving quality & compliance goals forward throughout the organization and achieving positive and value added results.

ADDITIONAL RESPONSIBILITIES:

  • Perform all other related duties as assigned by MQA Supervisor from time to time.

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE/EXPERIENCE

  • University degree or equivalent in Science and 3-5 years of previous QA experience in a pharmaceutical manufacturing environment.
  • Strong knowledge of Canadian and international regulatory and quality assurance regulations (HC, FDA, EU).
  • Excellent problem-solving skills, communication skills.
  • Training in microbiology and/or sterile manufacturing experience is an asset.

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs
  • This position requires vaccination for Hepatitis A and B
  • Job may require occasional extended shifts
  • While we appreciate all interest in this opportunity, only qualified candidates will be contacted.

Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.

NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.

Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources for assistance.

This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

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