At Bayer we\xe2\x80\x99re visionaries, driven to solve the world\xe2\x80\x99s toughest challenges and striving for a world where ,Health for all, Hunger for none\xe2\x80\x99 is no longer a dream, but a real possibility. We\xe2\x80\x99re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining \xe2\x80\x98impossible\xe2\x80\x99. There are so many reasons to join us. If you\xe2\x80\x99re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there\xe2\x80\x99s only one choice.
Quality Assurance Projects Specialist
The Quality Assurance Projects Specialist is responsible for corporate and regulatory requirements.
Bayer is committed to a flexible hybrid working environment.
What you will do:

• Independently manage assigned complex product portfolio for launches, MFG & PKG site transfers, products reformulations, line extensions, manufacturing or packaging process changes for Consumer Health and Pharma Division.
• Establish Project Related Master Products Documents.
• Provide support to non-triangulated Local and External Contract Manufacturing Organization (CMO).
• Lead and or participate in CMOs audits
• Leads the activities for negotiating, developing, and approval of Quality Assurance Agreements with local CMOs
• Review and approve Global Products Life Cycle Changes.
• Initiate and close projects related changes
• Support local CMOs total quality oversight program (QAAs, Deviations, Changes and MPDs).
• System release locally packaged SKUs and new product launches.
• Write and update SOPs
• Review and implement Global SOPs as required
• Record, upkeep, and report on a monthly basis Key Performance Indicators (KPIs),
• Provide technical support to a team of QA PM & Change Management (CM) members.

Who you are:

• Strong GMP level knowledge of Drugs, Natural Health and Medical Devices regulation
• Technical knowledge and experience of pharmaceutical products manufacturing and packaging processes
• Knowledgeable of requirements for drug establishment and site licensing
• Works with no or limited supervision
• Operates autonomously detecting and anticipating problems, and works together with team and manager to define solutions.
• Proposes changes to local procedures based on current practices.
• Proficient knowledge of MS Office computer software.

This position requires full vaccination against COVID-19.
What we offer:

• Competitive compensation and rewards package
• Collaborative, diverse and inclusive culture
• Career development and global opportunities
• Work-life flexibility programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offerings

Bayer is committed to fostering, cultivating and preserving a culture of Inclusion and Diversity. We embrace and encourage our employees\xe2\x80\x99 differences and believe that our people are our most valuable asset. The collective sum of individual life experiences, knowledge, innovation, self-expression, unique capabilities that our employees invest in their work represents our culture, reputation, and Bayer\xe2\x80\x99s values and purpose.
Learn more about our values and purpose at: https://www.bayer.com/en/ca/canada-our-purpose-values
All referral candidates must first be submitted via our internal referral system by a current Bayer employee in order to participate in the referral program. Once a Bayer employee has successfully referred you in our system, you will receive an automated email with instructions on how to complete your application.
Application Deadline: April 10, 2023
#LI-CA Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.
Location: Canada : Ontario : Mississauga
Division: Pharmaceuticals
Reference Code: 789331