Sr. Assoc, QA - IPQA

Posted 3 Days Ago
Be an Early Applicant
Ahmedabad, Gujarat
Mid level
Healthtech • Other
The Role
The Sr. Associate in QA is responsible for overseeing in-process quality assurance activities, including line clearance, sampling, compliance checks, and documentation. They will perform routine checks, handle training records, initiate batch numbers, and support corrective actions, ensuring compliance with manufacturing protocols and data integrity throughout the production process.
Summary Generated by Built In

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.

In Process Quality Assurance Activities i.e Line Clearance, FP Sampling, Shop Floor Compliance

  • To take instructions from Supervisor and shift lead to perform the shift activity.
  • To verify the correct raw material, primary packaging material, and Quantities are issued and dispensed as per the approved Batch records.
  • To perform the line clearance activity at various stages of manufacturing and packaging activity as defined in the BMR.
  • To perform routine In process checks, sampling, periodic verification, online documentation as defined in batch records and escalate any nonconformances to shift lead and supervisor and ensure appropriate actions (CAPA) in place.
  • To collect In-process samples, finished product samples, and other samples timely submission into QC/micro.
  • To review and verification of electronic records/Audit trails and printout of the equipment’s like autoclave, sterilizer, filter integrity machine and any other equipment’s etc.
  • To ensure the respective documents to be destructed as per approved procedure.
  • To ensure the compliance and GDP of logbooks, online documents, records, and other supporting documents related to products manufactured in the plant and data integrity is ensured.
  • To ensure & provide support to Shift Lead or Supervisor in investigation, in case of any product complaints or non-conformities or Out of Specification.
  • To execute the approved Corrective and Preventive Action (CAPA) with in define timeline.
  • To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure.
  • To prepare and review the SOPs.
  • To carry out stagewise BMR review for batch execution compliance.
  • To track the CPV Program through provided exhibits and to prepare the Minitab files for required products based on production plan for the month. To collect the data related to CPPs/ CQAs and shall perform data analysisy. Report any abnormality gap to supervisor /Shift lead.
  • To maintain the admin logins for all applicable equipments and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users.
  •  Initiation of batch number in BaxLIMS after proper verification of manufacturing and expiry date and correction of entries if required.
  • To approve the preventive maintenance activities in MAXIMO and risk assessment review and approval.
  • To ensure the handover of shift-to-shift activities and record in Shift charge Handover format/logbook.
  • To communicate about any failure or abnormal notification to Supervisor & shift lead for timely escalation and resolution.
  • To Perform impact assessment of breakdown maintenance and approve activity in MAXIMO and risk assessment review.
  • Material A.R.No. Stock Blockage or Un-blockage in System.
  • To perform the periodic building inspection with Admin team.
  • Any other responsibility assigned by shift lead and reporting manager.

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.

The Company
HQ: Deerfield, IL
35,858 Employees
On-site Workplace
Year Founded: 1931

What We Do

Every day, millions of patients, caregivers and providers around the world rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, kidney care, hospital and surgical products and solutions. For 90 years, we’ve been making an impact at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, therapies and digital health solutions available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations.

We welcome Hillrom to Baxter, where we are uniting to advance patient care worldwide. We’re building on the strengths of two historically innovative and socially responsible companies that will better serve our patients, customers and communities.

Similar Jobs

CrowdStrike Logo CrowdStrike

SDET II - MRC (Remote, IND)

Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
Remote
Hybrid
17 Locations
10000 Employees
Ahmedabad, Gujarat, IND
6028 Employees

Hitachi Logo Hitachi

Incoming Quality engineer

Fintech • Information Technology • Logistics
Maneja, Vadodara, Gujarat, IND
33676 Employees

Micron Technology Logo Micron Technology

Quality Engineer – Reaction Systems and Defect Management

Artificial Intelligence • Hardware • Information Technology • Machine Learning • Semiconductor
Sanand, Ahmedabad, Gujarat, IND
40000 Employees

Similar Companies Hiring

Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees
Artlist Thumbnail
Social Media • Other • Music • Digital Media
Tel Aviv, IL
450 Employees
Stepful Thumbnail
Software • Healthtech • Edtech • Artificial Intelligence
New York, New York
60 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account