This is where your 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.
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
What are some of the benefits of working at Baxter?
Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Commitment to growing and developing an inclusive and diverse workforce
#LI-MT1#IND-UKOPS#IND-UKCOM#LI-BAXGENEqual Employment OpportunityBaxter 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 AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .
