Assoc I, Quality Assurance
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.
Unique Opportunity
Come join Baxter Healthcare Corporation as a Sr. Executive Quality Assurance - IPQA Production in our brand new manufacturing facility in Ahmedabad. This role offers an exciting chance to be at the forefront of ensuring our products meet the highest standards of quality and safety. You will have a key role in upholding our reputation for excellence and be part of a dedicated team committed to making a positive impact.
Key Responsibilities
- Implement in-process quality assurance activities as delegated by the Supervisor and/or shift lead in each shift.
- Perform line clearance activities at various stages of packaging as defined in the Batch Packaging record.
- Perform regular checks during packing process following batch records and report any issues to shift lead and supervisor for necessary actions.
- Ensure challenge tests are performed at defined frequencies for applicable packaging equipment.
- Collect stability samples retain samples and other samples recording collection details in BPR and ELN.
- Verify the sample/good destruction process report any gaps to Shift Lead or Supervisor and take corrective and preventive actions in coordination with respective functions.
- Maintain compliance with Good Documentation Practices (GDP) for logbooks online documents and records related to our products.
- Perform Acceptance Quality Limit (AQL) of visually inspected products.
- Approve pallet planning in the PCR system at the dispatch area.
- Ensure cGMP compliance during packing and visual inspection processes.
- Perform evaluate and carry out Visual Inspection qualification processes.
- Prepare and maintain visual inspection qualification kits and records.
- Carry out stage-wise BPR review for batch execution compliance.
- Review and verify user access management and audit trails.
- Perform and support the Continued Process Verification (CPV) program.
- Ensure the handover of shift-to-shift activities and record in the Shift Charge Handover format/logbook.
- Perform impact assessments of breakdown maintenance approve activities in MAXIMO and review risk assessments.
- Participate in investigations in case of complaints or non-conformities.
- Communicate any failures or abnormal notifications to the Supervisor and shift lead for timely issue resolution.
- Raise Document Change Requests (DCR) and Change Control Management (CCM) supervise them and ensure closure as per Standard Operating Procedures.
- Perform any other responsibilities assigned by the shift lead and reporting manager.
Qualifications
- Validated experience in a quality assurance role within a manufacturing environment.
- Strong understanding of cGMP and GDP requirements.
- Outstanding attention to detail and dedication to maintaining high-quality standards.
- Excellent communication skills and ability to work collaboratively in a team-oriented environment.
- Ability to closely enforce to protocols and procedures.
- Proven ability to optimally conduct quality assurance processes and improvements.
Why Baxter
At Baxter you will be part of a collaborative and inclusive environment where your contributions are valued. We offer competitive compensation opportunities for growth and a chance to be part of a team that is committed to delivering outstanding products. Join us and make a difference in the lives of people around the world.
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 here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter 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 Recruitment Fraud Notice.
Key Skills
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About Company
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 ... View more
