Takeda Pharmaceutical Hiring for Senior Quality Assurance Specialist at Toronto, ON Full Time

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Job Description

Takeda is a patient-focused, values-based, R&D driven global pharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of life-changing treatments for patients are deeply rooted in our distinguished 237-year-old history in Japan.

Recognized as a top global employer, we continue to foster a diverse and inclusive work environment. By always putting people first, we empower employees so everyone can develop to his or her full potential. We are looking for colleagues with the right skills and experiences to support us in our commitment to improving healthcare for many generations to come.

Responsibilities:
As a key member of Shire Canada QA department, contribute to ensure that Shire Canada is compliant with local GMP and GDP requirements for Medicinal Products (mainly Biologics) and Medical Devices. Contribute to prepare for, host and respond to External and Internal inspections.

Support the effective implementation of Shire Canada Quality Systems: own local SOPs, and work on CAPA, Deviations, Complaints and Change Controls. Also, execute QC, batch review and batch release activities as requested by the Shire Canada QA Manager.

Establish relationship and work collaboratively to resolve quality issues with Shire Contract Distributors (CDOs), Distributor partners, Contract laboratories and Customers. Participate to establish Internal and External Quality Agreement as directed by the Shire Canada QA Associate Director.

Provide Quality support to the local operation, for both the existing business and the new product launches. Act as a deputy for Shire Canada QA Associate Director.

Review and approve all data generated in accordance with current Canadian GMP Regulations.

Provide technical support globally to external suppliers in order to ensure Shire’s commercial products are manufactured in compliance of GMP.

Support and assist in coordinating Global Affiliates activities in compliance with local regulations and Shire Global Quality Manual.

Contribute to ensure that Shire Canada establishes and retains all applicable licences and permits required to import and distribute Shire products on the Canadian market.

Requirements:
University degree or recognized as equivalent in Science related to the work carried out

Minimum 5 years’ experience working in Quality Assurance performing product disposition of parenteral (biologics), and devices or in manufacturing environment.

Interpersonal skills and professional skills to interact with contractors while representing Shire.

Experience working directly with CMO’s to resolve significant compliance deficiencies associated with downstream processing of biological products.

Thorough understanding of quality systems, cGMP’s and GDP’s.

Excellent knowledge of Health Canada GMP regulations, plus good awareness of other GMP requirements e.g. ICH, FDA.

Good Knowledge of BGTD release process

Desired:
Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)

Experience working with contract manufacturing

Experience interfacing with regulatory bodies and working on regulatory submissions

Key Skills, Abilities, and Competencies

English is mandatory

Ability to multi-task in environment with changing priorities

Good interpersonal and communication skills

Able to work with many organizations / cultures / quality systems

Locations

Toronto, Canada

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time