Quality Assurance Senior Associate - Change Management

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're 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 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Quality Assurance Senior Associate - Change Management

This opportunity supports the coordination and maintenance of the change management and master production documentation program within the pharmaceutical and Consumer Health industries, in accordance with local, global and regulatory requirements.

Bayer is committed to a flexible hybrid working environment. This is a 12-month term position based out of Mississauga, Ontario.

What you will do:

• Initiate, review and approve change controls to include impact assessment and prioritization based on risk
• Ensure timely review (compliance with change) and completion (in accordance with pre-defined timelines) of change action items
• Escalate any potential compliance gap during change and document review as required
• Manage Change Management Global Systems SOPs, training and systems improvements initiatives
• Act as the SME for global change management systems
• Evaluate opportunities to create partnerships with internal and global functions as a means of developing and implementing initiatives to drive quality and business objectives
• Collaboration with Internal Quality teams for internal systems improvements
• Manage Master Production Document Program and associated SOPs
• Review Master Production Documents as per Health Canada Requirements
• Educate Supply Centers on Canadian specific requirements
• Provide suggestions and recommendation to Change Management processes.
• Record, upkeep, and report on a monthly basis Key Performance

• Support KPI metrics evaluation to drive improvements

• Manage training and personal development Plan

Who you are:

• University Degree or College Diploma in chemistry, biochemistry or a related science
• Good understanding of Change Management principles
• Strong Good Manufacturing Practices (GMP) level knowledge of Drugs, Natural Health and Medical Devices regulation
• Technical knowledge and experience in pharmaceutical products' manufacturing and packaging
• Knowledgeable of requirements for Drug Establishment License (DEL) and Site License (SL) is an asset
• Works well in both individual and team setting
• Operates autonomously, detecting and anticipating problems, and works together with leads to define solutions
• Experience in processing changes to local procedures based on current practices (initiating and managing closure)
• Proficient knowledge of computers software (e.g., MS Office)
• Strong organizational and English communication skills
• Experience in working with imported pharmaceutical and (Natural Health Products) NHP products will be an asset

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' 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's values and purpose.

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.

This posting will be available for application until at least Jan 11, 2025.

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:

835860