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Pharma Quality Assurance Specialist Job @ Shire | Toronto

Pharma Quality Assurance Specialist Job @ Shire | Toronto

Pharma Quality Assurance Specialist Job @ Shire | Toronto:  Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Pharma Quality Assurance Specialist Job @ Shire | Toronto

Posting Title:  Sr Quality Assurance Specialist

Job ID:  16231BR

Function: Technical Operations

Division: Quality

Employee Type: Regular

Level: SRPR I

Search Location(s): Canada – Toronto

Job Category: Quality Assurance

Job Description Primary Role:

  • As a key member of Shire Pharma Canada ULC QA\QC department, contribute to ensure that Shire Canada is compliant with local GMP and GDP requirements for Medicinal Products and Medical Devices. Contribute to prepare for, host and respond to External and Internal inspections.
  • Support the effective implementation of Shire Pharma Canada ULC Quality Systems: own local SOPs, and work on CAPA, Deviations, Complaints and Change Controls. Also, execute QC, batch review and batch release activities as required.
  • Establish relationship and work collaboratively to resolve quality issues with Shire Contract Distributors (CDOs), Distributor partners, Contract laboratories and Customers.
  • Audit third parties and establish Internal and External Quality Agreement as required with the Associate, QA Director.
  • Provide Quality support to the local operation, for both the existing business and the new product launches.

Responsibilities:

  • Contribute to prepare for, and participate in GMP and GDP inspections for Medicinal products and Medical Devices.
  • Contribute to provide an assessment of new applicable Regulations on the Canadian LOC, and execute the related CAPAs.
  • Participate in the elaboration of local SOPs and execute quality activities such as Change Controls, CAPAs, Deviation Investigations, Mock recall, Complaints, etc…
  • Perform batch documentation review, confirmatory testing raw data review and QC activities, and determine batch disposition as per Canadian Batch Release SOP. Liaise with suppliers regarding any queries on batch documentation.
  • Work collaboratively with local CDO(s) and Distributor partners; Handle returns, rejects and destruction; and oversee product rework.
  • Participate in QTA and Quality review meetings as required with the Associate, QA Director. Prepare the change control for Internal and External Quality Agreement.
  • Review and Manage temperature excursions and Transport and Distribution deviations.
  • Support GMP\GDP training program for Shire Pharma Canada ULC impacted personnel.
  • Maintain and further develop competence in GMP\GDP through regular training, benchmarking with colleagues, and coaching from Subject Matter Experts.
  • Review and approve artwork for printed packaging materials.
  • Act as a deputy for Shire Pharma Canada ULC Associate, QA Director.

Education & Experience Requirements:

  • University degree or degree recognized as equivalent in Science
  • Practical experience of at least 3-5 years in the Pharmaceutical Industry, mainly in QA/QC environment
  • Experience with suppliers and customers
  • Excellent knowledge of Health Canada cGMP & cGDP regulations
  • Experience in a global environment (asset)

Key Skills, Abilities, and Competencies: (Only include if there is enough room)

  • Good degree of autonomy, able to work with limited supervision
  • Ability to multi-task in environment with changing priorities
  • Good interpersonal and communication skills
  • Able to work across levels and functional and geographical boundaries
  • Bilingualism is required – French and English
  • Look for practical and compliant solutions to issues
  • Understands potential impact and contributes significantly to the resolution of simple or complex issues arising
  • Work with numbers of suppliers / products
  • Facilitate troubleshooting, and tackle non-routine work and projects independently
  • Offers constructive comments and propose improvements and rationalizations to systems, policies and procedures
  • Use judgement to assess which information must be referred upwards and what can be handled independently.

 

Pharma Quality Assurance Specialist Job @ Shire | Toronto

How To Apply & View Original Notification: https://sjobs.brassring.com/TGWebHost/jobdetails.aspx?jobId=1164211

 

 

 

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