We have requirement for Sr Associate, Quality - PAC

Job Description

Sr Associate, Quality - PACApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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 prepare, review and execute quality and distribution agreements with various business partners/Baxter Regional Plants/ Marketing Authorization Holders (MAH)/ Batch release sites (BRS)/Qualified Persons (QP) as applicable.
• To review and upload the approved quality and distribution agreements in TCU.
• To prepare and update the agreement index on quarterly basis and share with relevant stakeholders as per applicable.
• To prepare the agreed obligations as per respective quality agreements and share the approved copies of obligations with Batch release team to ensure their compliance and with other relevant stakeholders as applicable.
• To share the batch documents with different business partners of different regions but limited to EU, Canada, South Africa, Russia, US as agreed in respective Quality agreements.
• To assess and notify the change controls, DCRs, OOS, NCR, SNCRs with different business partners of different regions but limited to EU, Canada, South Africa, Russia, US as agreed in respective Quality agreements.
• To share the applicable supplier audit reports, PQRs, validation reports and stability summary reports with different business partners of different regions but limited to EU, Canada, South Africa, Russia, US as agreed in respective Quality agreements.
• To share the applicable master batch records alongwith supporting QMS documents applicable for revision with different business partners of different regions but limited to EU, Canada, South Africa, Russia, US as agreed in respective Quality agreements.
• To share the response for the received queries and concerns from QP/partners in submitted documents but not limited batch release in territory.
• To arrange and share for the required working standards, samples, impurities required for testing in respective country as agreed in respective Quality agreements.
• To prepare and share the quarterly report for PAC function summarizing the details of activities executed in each quarter.
• To arrange/participate in discussions/meeting/calls with different stakeholders internally and externally on but limited to CCNs, Market complaint, NCRs/SNCRs, OOS as required and as applicable.
• To participate in New product launch covering different aspect of country specific requirement and coordinate the requirement with relevant stakeholders as applicable.
• To provide support to Cross functional teams in investigation, in case of any product complaints or non-conformities or Out of Specification, as applicable and required.
• To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS).
• To discuss for implementation of feedbacks/suggestion received for system enhancement from QP/partners/MAH /Baxter Other sites as applicable.
• To preparation, review, implement and update SOP s according to current regulations systems.
• To raise Document Change Request (DCR) and Change Control Management (CCM) for SOP revision and other required tasks not limited to CAPA and track the same and ensure closure as per Standard Operating Procedure.
• To give non-compliance reports to the respective departments identified during review of document/activities relevant to their function.
• To collect, compile and provide data for Management Information System.
• To prepare budget for purchase of all the requirements related to PAC activities.
• To perform internal quality audits to ensure the compliance to all systems and procedures.
• To ensure process and systems are complying as per standard written procedures.
• To support external audit process as per role assigned by CQA Head.
• To ensure compliance of regulatory intelligence as and when received.
• To communicate about any failure or abnormal notification for their attention and seeking for the solution.
• To seek area of improvement from and implement action plan.
Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to hidden_email 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 .099677Apply Now Save Job,

Keyskills :
batch recordsquality auditquality management systeminternal quality auditoraudit reports