Sr Exec, QA - Doc Control

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.

Key responsibilities & authorities

Your role as Sr Exec, QA - Doc Control at Baxter Healthcare Corp is to craft quality assurance processes in Ahmedabad manufacturing.

Tasks:

• Take instructions from the supervisor or QA Head to handle Document Control activities.
• Ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards.
• Review and verify that any GDP (Good Documentation Practice) issues have been addressed.
• Issue and close Logbooks to the respective plant, as per the request of respective departments from the Controlled Forms System (CFS).
• Store completed Logbooks, Standard Formats, and Batch Manufacturing Records in the record room and submit them to the central record room.
• Issue completed records from the record room and ensure their storage, archiving, and timely disposition.
• Check BMR and BPR for new products in manufacturing, whether for regulatory filings or commercial distribution.
• Review BMR based on initial product transfer input received from Quality or F&D / TTD as the need arises.
• Prepare and review BMRs and BPRs by integrating product specifications from the Technical Package (TP) and processing parameters from the site.
• Verify BMR and BPR in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment.
• Review departmental Standard Operating Procedures (SOP) and keep them updated by providing inputs for IPQA functions as per regulatory guidelines.
• Maintain the Bill of Material and build HALB codes in JDE.
• Review cross-functional SOPs and keep them updated by providing inputs for Document Control functions as per regulatory guidelines.
• Prepare annual product review reports and submit them to IRA for dossier updates.
• Prepare change control management (CCM) or document change requests (DCR) for Document Control.
• Raise Non-conformance Reports (NCR) and complete investigation reports with appropriate corrective and/or preventive actions for any non-compliance during Document Control activities.
• Complete tasks for Corrective Action and Preventive Action (CAPA).
• Complete tasks for Change Control Management (CCM).
• Regularly prepare, review, or revise SOPs to align with regulatory requirements or address internal audit observations (if any).
• Support cross-functional department staff with any Batch records-related query resolution.
• Generate and review stability intimation slips in ELN.
• Seek areas of improvement from the QA Head and implement action plans.
• Communicate any failures or abnormal notifications to the Supervisor and QA Head for their attention and solutions.
• Communicate any gaps or abnormalities observed during data verification to the Supervisor or QA Head.

Your role is pivotal in maintaining the outstanding quality standards that Baxter Healthcare Corporation is known for. By technically adhering to regulatory guidelines and efficiently implementing our quality assurance processes, you will help us challenge at the highest level in the global healthcare market.

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.

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