Quality Specialist

1 week ago

Mississauga, Ontario, Canada GlaxoSmithKline Full time
Site Name: Mississauga Milverton Drive
Posted Date: May

This is a 24 month contract position.

JOB PURPOSE

This role is responsible for managing quality assurance activities supporting the Canadian Rx Commercial business (Importation/ Distribution).

PRIMARY RESPONSIBILITIES

  • Retrieve, review, and summarize Periodic Product Reviews supporting Canada imported / distributed products; escalate product performance trends,
  • Retrieve, review, and summarize Annual Stability Reports supporting Canada imported / distributed products; escalate out of trend and specifications results,
  • Perform batch release activities per Health Canada Regulations for Imported / Distributed products,
  • Produce trending reports, KPIs on weekly / monthly basis and summarize trends
  • Liaise with 3rd party customers, logistics providers, providing direction and support as required
  • Revise and approve Quality SOPs for the Canada Rx business
  • Perform duties of a Training Coordinator and Documentation Administrator per local procedures
  • Manage, support and trend training, as required per local procedures as the Training Administrator,
  • Perform documentation archiving per local procedures
  • Support regulatory or 3rd party audits with document preparation, control room support Manage and support the documentation repository, as required per local procedures, as the Documentation Administrator
  • Coordinate and support changes impacting products/processes for the Canadian Rx market, including product launches,
  • Manage product quality complaints originating from Canadian market; review investigation reports from investigating sites; liaise with Drug Safety and Customer Service for complaints processing, trend and analyze complaints data, report conclusions and required actions,
  • Negotiate, review and approve Quality Agreements with supply sites
  • Maintain product specifications in line with registration details for Canada marketed products
  • Initiate deviation records and coordinate / conduct investigations identifying root cause and CAPA
  • Participate in improvement projects for Quality systems and other special projects and initiatives
  • Perform Self Inspection audits

BASIC QUALIFICATIONS

  • Bachelor of Science or Engineering degree or equivalent
  • Minimum 3 years pharmaceutical industry experience (within Quality Assurance or Regulatory Affairs)
  • Strong knowledge of QA systems, processes and related regulatory requirements (cGMPs)
  • Demonstrated risk-based decision-making skills
  • Demonstrated proficiency in computer systems

PREFERRED QUALIFICATIONS

  • Strong understanding of the regulatory framework within Canada pertaining to Drug Products and Medical Devices
  • Demonstrated results in a cross functional environment
  • Excellent organizational and communication skills (verbal and written)
  • Demonstrated ability to prioritize work, adapt to change, meet objectives / deadlines.
  • Experience with software solutions for managing business operations for QA/GMP environments (e.g. SAP, VQMS, etc)
  • Understanding of manufacturing and packaging processes, as well as supply chain, is an asset
  • Ability to analyze data, trend, and determine corrective actions.

#LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an equal opportunity employer committed to diversity and inclusion.We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada- do not send resumes to this e-mail and instead apply through the online application process of this posting.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


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