QA Validation Specialist - Pharmaceutical

If so this could be a role for you...

Our client in the Life Sciences field has partnered with Randstad Engineering in their search for QA Validation Specialist to join their team in the Burlington area.

In this role, you will be working on all QA and validation-related activities for the site.

This is a 12 months contract with a potential extension or hired perm.

Advantages
Global brand
a lot of opportunities to learn
potential extension or hire
competitive salary
vacation pay

Responsibilities
- Provide validation and QA support for processes, equipment, products, software, cleaning, computerized systems, and facilities that have been newly developed, installed, upgraded, replaced or modified.
- Lead the review and statistical analysis of validation results and summarize results in validation reports.
- Coordinate validation activities related to external vendors/service providers.
- Ensure the quality of products, services and suppliers in compliance with external regulations (i.e. ISO 9001) and customer quality requirements.
- Support on-going continuous improvement QA projects i.e. establishing data integrity framework, revamping supplier management, external audit program based on LS policies.
- Support day-to-day operations and QA related activities as needed.
- Creating, modifying and issuing SOPs, procedures, templates, forms and other documents as required.
- Assisting with follow-up on open NCRs, CRs, and ensuring tasks being completed in a timely manner.
- Support operations-related activities through the creation of MBRs, timely product review and release, creation of labels, conducting sampling and inspections.
- Assist during audits including internal, customer, third party etc.
- Responsible for assisting with daily, weekly, monthly, yearly QA activities including but not limited to: temperature monitoring, logbook review, raw material receiving, receiving and obsoleting equipment, supplier
management, calibration program and documentation control activities.
- Utilize SAP in order to complete QA related tasks
- All other duties as assigned

Qualifications
- Bachelor’s Degree in Engineering, Applied Science or other relevant science/life science-related discipline required
- 2+ years industry validation experience required in an environment regulated by a Quality Management System in at least one of the following areas: production equipment and utilities qualification, product/production
processes validation, cleaning validation, test method validation, analytical instrument validation, software validation, facilities qualification
- 2+ years experience in quality assurance
- 2+ years experience in life science manufacturing/biotech industry
- Experience working within an ISO 9001 regulated environment
- Experience writing reports, summaries, protocols and SOPs
- Familiarity with FMEA/risk analysis, product failure analysis

Summary
If this sounds like a great fit for you please send your resume to Swapna Nair at swapna.nair@randstad.ca

** Only qualified candidates will be approached

Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.

Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.