Assoc Eng, Eng Services

2 weeks 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.

To investigate, review and approve any Out of limit (OOL) or Non-conformity Report or Laboratory Incident and take the corrective and preventive actions (CAPA) if required.

To facilitate internal quality audits to ensure the compliance to all systems and procedures.

To ensure that system and facilities comply as per the regulatory requirements and expectations.

To ensure and sustain all time readiness in line with current regulatory expectations for regulatory authorities and other partner inspection.

To ensure process and systems are complying as per standard written procedures.

To ensure compliance against audit observations and ensure effectiveness of Corrective & Preventive Action (CAPA).

To ensure completion of assigned training of Utility Department.

To operate electronic QMS modules for review and approval of changes, procedures for Utility Department.

To ensure that data integrity is being maintained at all levels and to perform regular checks to ensure that system is in state of control.

To ensure that the key responsibilities are well defined, built into the executor level and monitored periodically.

To ensure Department is in line with cGMP compliance as per global regulatory requirements

To prepare and update the error free and user-friendly documents.

To raise Change Control for any changes in approved processes and system. Also execute & close impact analysis and Change Control Tasks in timely manner.

To review & investigate Quality Management System (QMS) elements such as non-conformance (NCR), Corrective & Preventive action (CAPA) for Utility in Track wise.

To attend and implement training related to Quality Management System (QMS) and current Good Manufacturing Practice (cGMP) and ensure the on-time training completion of Utility Team.

To check & verify that data integrity is being maintained at all levels by frequent GEMBAs.

To act as Author and prepare Quality Management System (QMS) related documents such as Standard Operating Procedure (SOP), Exhibit, Standard Format, User requirement specification (URS), Qualification protocol, etc. in TcU and ensure the documents are in line with current Good Manufacturing Practice (cGMP) requirements

To track & comply with Quality Key Performance Indicators (KPIs) metrics & take corrective action to ensure such performance metrics are within the target achievement.

To face an internal or external current Good Manufacturing Practice (cGMP) regulatory audits & respond to the auditors’ queries. Also ensure audit preparedness in the function.

To escalate to Manager if any abnormalities or non-compliance in Utility function

To assist Manager carrying out Energy saving activity and its monitoring system continuously with every year Energy reduction goal.

To assist Manager in carrying out projects for awareness of safety, improvement in operation efficiency and cost optimization.

**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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