Releaser, QA

Overview

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

We are seeking a Quality Assurance Releaser to join our Stockport Compounding site on a rotational shift of 6am-2pm and 2pm-10pm, Monday to Friday.

Responsibilities

• Product Release
  • Rotational shift, 6am to 2pm and 2pm to 10pm alternating weekly.
  • Responsible for ensuring that all product released meets specification and customer requirements.
  • Responsible for ensuring that all product undergoes effective visual inspection, release checks and has been manufactured in compliance with GMP and quality system requirements.
  • Responsible for ensuring no product is released before a formal assessment for the impact of the deviation is made and a disposition is approved.
  • Responsible for ensuring the disposition of products and raw materials/components impacted by non-conformances is appropriately documented and completed in a timely manner.

• Communication and Training
  • Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance
  • Attends and participates in QA Team meetings
  • Ensures their own understand their responsibilities under the quality system regulations
  • Ensures training is delivered with staff to enable them to complete their jobs in compliance with the Baxter quality systems and country regulations
  • Supports the communication of changes of the quality system to staff, ensuring appropriate training programs are executed.
• Quality System Measurement and Review
  • Attends and participates in monthly quality review meetings when required
  • Ensure assigned meeting actions are completed to agreed deadlines
• Complaints
  • Ensures all incidents reported by customers are appropriately escalated to line management
  • Management of complaints using the pilgrim PMDA software if required
  • Raising supplier complaints with Line management to address out of specification raw material issues
• Non-Conformance and Corrective and Preventative Action (CAPA)
  • Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated
  • Initiation and investigation of Non-conformance/CAPA event reports as required
  • Monitor all quality system processes to detect need for improvements
  • Non-Conformance/CAPA owner and leader as required
  • When required, ensure Non-conformance/CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames
• Change Control
  • When required, maintain a local change control process to ensure all changes are fully documented
  • Support the assessment for risk and impact prior to change implementation
  • Support the implementation of changes as per impact assessment and in the appropriate time frame
• Validation
  • Responsible for Approval of validation protocols and reports if required
• GMP and Facilities and Equipment Control
  • Responsible for the Quality review of environmental monitoring results when required
  • Support Environmental, Health & Safety (EHS) programme
• Risk Assessment
  • Supports the site risk management process
  • Supports the update of risk assessments as a result of quality system measurement and review and change management.
  • Actively manages risks by identifying potential failure modes.
• Audit Management
  • Ensures that the facility is always ready for an internal, Corporate, MHRA or 3rd party audit
  • Support the audit processes to ensure effective audit management
• Document and Data Management
  • Ensures there are no unauthorized changes to documents including creation of local documentation.
  • Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
  • Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible

Benefits

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice
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