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Compliance Specialist

Req #: 1800005U_en
Location: Mississauga, ON CA
Job Category: Clinical
Date Posted: 1/22/2018 1:09:41 PM
Baxter International

Description

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

 

Facility Compliance:

Liaise with vendors for critical & non-critical maintenance. Plan annual calendar for calibrations, certifications, maintenance and cleaning, PVs.

 

• Collaborate with QA team for changes to corporate or regulatory standards that impact on facility maintenance and calibration/certifications

• Notify contractors of any changes to standards or procedures

• Ensure new contractors receive site orientation and training, as appropriate

• Update Preventative Maintenance task list as appropriate, and activities completed to schedule

• Source vendors for facility maintenance as required and engage contractors per management decision

• Review results and follow up / investigate OOS results

• Support ISO Train system updates as necessary

• Manage the GMP Calendar

 

NCRs and CAPA, Audits:

Perform quality related investigations with QA and site operations team, and provide information for responses to quality issues (NCRs, CAPA, Complaints, Audits etc.)

 

• Work with the Operations and QA teams to ensure readiness of the site for any internal or external inspections / audits

• Preparation of responses to QA investigations (CAPA, complaints, non-conformances) and audit processes as required

• Use Human Factors toolkit to identify root causes of human failure and effect corrective actions accordingly.

• Apply root cause analysis of quality incidents to improve operational processes

 

Change Control Management:

Preparation and execution of Change Control tasks

 

• Lead in risk and impact assessment for changes to procedures, facility and equipment, including validation of new equipment.

• Implementation of process changes identified through efficiency or continuous improvement programs, ensuring compliance of CIVA operations to all regulatory, corporate and legal requirements and procedures

 

Policies and Procedures, including Stability:

Development and review of CIVA procedures to meet operational needs. Oversee compliance of operations and products to PS procedures and stability information

 

• Preparation of updates and changes to CIVA procedures using Baxter software

• Communicate pending SOP changes to the Training Manager to ensure group training is completed prior to SOP effective date (training summary)

• Assist with training in relevant areas of procedure review and process improvements

Qualifications

• Science Graduate, Pharmacist or equivalent 

• Experience in pharmaceutical compounding in either hospital or private organisation

• Knowledge of the principles of cGMP

• Thorough knowledge and adherence to CIVA procedures

• Ability to build and maintain effective relationships with internal/external customers

•  Ability to prioritise tasks

• Ability to make decisions on sound professional judgement

 

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

 

Thank you for your interest and application to Baxter.  All applications will be reviewed and those candidates selected for consideration will be contacted directly.

 

Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.

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