Associate, QA Ipqa

3 months ago

Ahmedabad Gujarat, India BAXTER Full time

**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.

At Baxter Healthcare Corporation, we are seeking a diligent and meticulous Associate, QA IPQA to join our Manufacturing team in Ahmedabad. This role offers an outstanding opportunity to be part of a dynamic environment where you can contribute to our mission of delivering detailed healthcare solutions. You will play a crucial role in ensuring the highest standards of quality and compliance while collaborating with a team of especially skilled professionals.

**Key Responsibilities**:

- Carry out tasks assigned by the Supervisor and Shift Lead to implement shift activities.
- Verify that accurate raw materials, primary packaging materials, and quantities are issued and dispensed according to approved Batch records.
- Perform line clearance activities at various stages of manufacturing and packaging as defined in the Batch Manufacturing Record (BMR).
- Conduct routine in-process checks, sampling, periodic verifications, and online documentation as outlined in batch records.
- Advance any non-conformances to Shift Lead and Supervisor, ensuring successful implementation of Corrective and Preventive Actions (CAPA).
- Collect and submit in-process samples, finished product samples, and other samples to QC/micro in a timely manner.
- Review and verify electronic records/audit trails and printouts from equipment such as autoclaves, sterilizers, and filter integrity machines.
- Ensure documents are destructed according to approved procedures.
- Maintain compliance and Good Documentation Practices (GDP) for logbooks, online documents, records, and other supporting documents related to manufactured products, ensuring data integrity.
- Support investigations in cases of product complaints, non-conformities, or Out of Specification (OOS) results.
- Complete approved CAPA within specified deadlines.
- Raise Document Change Requests (DCR) and handle Change Control Management (CCM), ensuring closure as per Standard Operating Procedures (SOPs).
- Prepare and review SOPs.
- Carry out stage-wise BMR reviews for batch execution compliance.
- Track the Continued Process Verification (CPV) Program using provided exhibits and prepare Minitab files for products based on the monthly production plan.
- Collect data related to Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), perform data analysis, and report any abnormalities to the Supervisor/Shift Lead.
- Maintain admin logins for applicable equipment, provide new logins, activate and deactivate user accounts, and perform periodic verification and access control.
- Initiate batch numbers in BaxLIMS after verifying manufacturing and expiry dates, and accurate entries if required.
- Approve preventive maintenance activities in MAXIMO, conduct risk assessments, and ensure shift-to-shift activity handovers are recorded.
- Communicate failures or abnormal notifications to Supervisor and Shift Lead for timely resolution.
- Perform impact assessments of breakdown maintenance and approve activities in MAXIMO.
- Handle Material A.R. No. Stock Blockage or Un-blockage in the system.
- Conduct periodic building inspections with the Admin team.
- Any other responsibilities assigned by the Shift Lead and Reporting Manager.

**Requirements**:

- Validated experience in a quality assurance role within a manufacturing environment.
- Strong understanding of GMP, GDP, and SOPs.
- Excellent attention to detail and organizational skills.
- Proficiency in adhering to guidelines and procedures.
- Outstanding communication and collaboration abilities.
- Proficiency in data analysis and process verification.
- Competence in using quality management systems and tools like BaxLIMS and MAXIMO.

**Reasonable Accommodations**

**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.

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