Job Description

Are you looking for an opportunity to support a Quality Management team in the day to day operations in a manufacturing environment? If so, this is the role for you.

As Operational Quality Assurance Staff you will be responsible for supporting the local operating company manager to implement and maintain and effective and robust quality management system. You will also perform day to day quality operations to ensure lean and efficient ways of working to meet compliance standards.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Execute and deliver quality objectives, quality improvement plan, and trends against the quality key performance indicators to drive continuous improvement
• Monitor quality performance and key performance indicators assigned to third parties to ensure quality and compliance issues are identified, communicated, and resolved
• Support the local change control process to ensure all planned major changes are effectively and compliantly managed
• Perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks
• Develop local processes to conduct root cause analysis; identify where corrective/preventative actions plans are required and ensure they are effectively implemented, monitored, and closed out
• Support the complaints management process to ensure potential issues are determine quickly, linked to the adverse events, reported, and follow up on product complaints
• Liaison with external suppliers for products that are manufactured by contractors to ensure compliance to local registered technical details
• Support the Quality Manager to ensure that an effective local product incident process is in place and manage any product quality related issues and train staff as appropriate
• Work daily to support systems that have an impact on the quality of imported products and the products are in line with the quality management system
• Liaison with manufacturing sites to ensure compliance to local registered technical details
• Ensure the timely release of imported finished goods deliveries and resolve quality-related issues from deliveries
• Communicate with Global Manufacturing Supply sites regarding regional quality as it relates to approval of repacking activities and resolving quality issues with the product supplied
• Perform daily support of repacking to ensure batch release orders are compliant and meet regulatory guidelines before distribution and/or re-export
• Ensure all product specifications and related documents are maintained and compliant to current registered details
• Support Quality Manager in ensuring product storage and distribution performed by third party warehousing and distribution service providers complies with GSK standards
• Ensure as appropriate documentation of batch records and retention of samples

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor\xe2\x80\x99s degree
• 2+ years\xe2\x80\x99 experience within the Pharmaceutical/Consumer Healthcare industries
• Experience in quality assurance systems particularly in the areas of batch release, repacking, product incidents, artwork control and performing self-inspection
• Experience with regulatory requirements pertaining to good manufacturing practices and good documentation practices
• Experience working with effective quality documentation systems

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Previous role as a quality associate or specialist
• Good written and verbal communication skills
• Analytical thinker with good attention to detail and problem-solving skills in a structured process
• Team player with the ability to work in cross-functional teams
• Ability to multi-task and work under pressure
• Identify areas of continuous improvement and innovative ways of working
• Ability to demonstrate flexible thinking
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making \xe2\x80\x93 using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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\xe2\x80\x99re 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 . 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\xe2\x80\x99 offices and dentists\xe2\x80\x99 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.

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.

GlaxoSmithKline