Quality Specialist - Loc Rx

Site Name: Canada - Ontario - Mississauga
Posted Date: Jul 21 2023
Are you excited by an opportunity to get your foot in the door of great, global, pharmaceutical company? Do you have a passion for working in the Canadian Rx Commercial business? This may be the right job for you!

• Only candidates currently living in Canada, with the legal right to work here, will be considered
• This is a 12-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,
• Participate in improvement projects for Quality systems and other special projects and initiatives
• Liaise with 3rd party customers, logistics providers, providing direction and support as required
• Initiate deviation records and coordinate / conduct investigations identifying root cause and CAPA
• Retrieve, review, and summarize Annual Stability Reports supporting Canada imported / distributed products; escalate out of trend and specifications results,
• Produce trending reports, KPIs on weekly / monthly basis and summarize trends
• Maintain product specifications in line with registration details for Canada marketed products
• Negotiate, review and approve Quality Agreements with supply sites
• Perform Self Inspection audits
• Manage, support and trend training, as required per local procedures as the Training Administrator,
• Perform batch release activities per Health Canada Regulations for Imported / Distributed products,
• Revise and approve Quality SOPs for the Canada Rx business
• 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,
• Perform duties of a Training Coordinator and Documentation Administrator per local procedures
• Perform documentation archiving per local procedures
• Coordinate and support changes impacting products/processes for the Canadian Rx market, including product launches,
• 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

Basic Qualifications

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

Preferred Qualifications

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

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.
Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19. Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.
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