Quality Assurance Projects Specialist

2 months ago

Mississauga, Canada Bayer Full time

**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 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’ 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.

Application Deadline: April 10, 2023

LI-CA

**Location**:
Canada : Ontario : Mississauga

**Division**:
Pharmaceuticals

**Reference Code**:
789331

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