- Preparation and execution of Change Controls, writing validation protocols, coordinating testing/validations of new product samples and equipment
- Leading stakeholder meetings with relevant Quality and Operations stakeholders to achieve target project timelines
- Development of process improvements to facilitate operations including testing and implementation of new versions into site operations and customers
- Ensuring accurate and timely set up of compounding components and other data in compounding production IT systems (i.e., Merlin, Mercury)
- Assisting with system validations
- Development and review of operating procedures and documents to align with project milestones
- Working with Training team members to facilitate training activities associated with compounding projects and new initiatives where required
- Perform Quality-related investigations as required and contribute to responses for Quality issues (NCR, CAPA, Audits etc)
- Consistent adherence to Quality and Regulatory requirements ensuring compliance
- Other responsibilities as assigned
- Post-secondary degree or diploma in sciences or equivalent
- 3+ years in Compounding Operations or Quality
- Experience managing Change Controls
- Experience writing validation protocols
- Strong technical writing abilities
- Experience as a key contributor to significant operational validations and/or system implementations
- Demonstrated ability to work both independently and collaboratively as part of a team
- Demonstrated ability to take independent initiative and follow direction
- Proven ability to make decisions based on sound professional judgement
- Demonstrated success in a role that requires significant prioritising, organising and multi-tasking
- Excellent attention to detail
- Strong written and verbal communication skills
- Strong computer skills with Microsoft 365 (particularly excel, Word, ppt)
- Ability to articulate understanding of, and commitment to, continuous improvement
- Registered Pharmacy Technician or Bachelors degree in science or equivalent
- Strong experience with computer systems used at CIVA
Strategic Projects Associate - Mississauga, Canada - Baxter
Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Your Role at Baxter:
In this role, you will be responsible lead and execute strategic operational projects and initiatives at CIVA to ensure coordinated and efficient implementation including the writing of validation protocols.This role will be required to work collaboratively within the Quality and Regulatory framework ensuring robust documentation of all project parameters.
What you'll be doing:
What you'll be having:
Nice to have:
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