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Sr Assoc, QA

3 months ago

Ahmedabad, 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 monitor various departmental activities (including clean-room behavior) in all three shifts for Quality Oversight. To manage and allocate the shift resources for various activitie To ensure and perform the line clearances of process and packaging activity, in-process checks as per defined frequency, online review of Batch records to ensure compliance and Good documentation practices. To ensure and perform the sampling of finished goods, in-process samples, retain samples, stability & elemental impurity samples, batch testing samples and other samples as required are as per procedure and handed over accordingly. To ensure the review and verification of electronic records/Audit trails and batch related printout of all the equipment as applicable. To overview and ensure the activity are being performed as per the defined procedure for dispensing, mixing process, filtration, filling, capping, terminal Sterilization, visual inspection, packing and dispatch of the batch. To ensure and verify that there shall be no data integrity breach at any stage of the manufacturing and packing process. To ensure and review of the alarms of EMS/BMS system and any other equipment’s if any. To verify the dispatch activity are being performed as per the defined process. To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards and all applicable quality standards in the plant. To ensure that every batch of product meets the defined standards for strengths, identity, safety, purity, and quality. To take corrective and preventive actions by performing root cause analysis for complaints and nonconformities to minimize recurrence. To review validation reports, corrective, and preventive action (CAPA) reports and approval of the validation reports, etc. To take deep dive into problems encountered & discuss the cross functional team to ensure compliance. To conduct the regular shop-floor rounds and report the findings with immediate action taken in the shift to respective functions. To track the CPV Program in MINITAB through provided exhibits and ensure its compliance and escalation of any signals identified To maintain the admin logins for all applicable equipment’s and to provide the new logins, activation & deactivation for users and periodic verification & access control of all users and review of audit trail reports. To initiate the batch number in BaxLIMS and ensure its correctness. To approve the Workorders/Breakdown reports/ 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 ensure periodic clean room inspection as per approved schedule and its compliance. To ensure the timely removal and destruction of documents as per approved procedure. To carry out reconciliation and physical verification of the returned goods. To escort and engage the personnel from regulatory agencies as per requirements. To support in fetching and compiling data required for during reviewing performance of Quality Assurance at regular frequency by Quality Head. To prepare and review of SOPs pertaining to IPQA and review of SOPs pertaining to cross functional departments. To assess the continuity of the process or activity in consultation with line manager and cross-functional team members for any non-compliances observed. To ensure immediate escalation for any decision needed on key quality or process or operations to the respective functions. To perform the periodic building inspection with Admin team. ny IPQA activity other than mentioned above assigned by reporting manager.

Preferred Educational Qualification: M Pharm, MSc, B Pharm, Bio Tech Graduates/Post Graduates