Sr Quality Engineer
This is where your work makes a difference.
At Baxter, we believe every person regardless of who they are or where they are from deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job you will find purpose and pride.
- To review executed protocols of equipment, utility, process validation, cleaning validation, Utility and facility /HVAC qualification.
- To coordinate with cross functional departments for execution of all validation activities & escalate to HOD regarding any non-conformity from planning.
- To review calendars for various periodic qualifications & get it reviewed and approved by HOD.
- To track QMS documents like Change Control Management, Corrective and Preventive Action, OOS and Non-conformance for the validation activity and review and approve the investigation report.
- To ensure timely closure of the DCRs, CCM tasks, investigation report due to any NCR/OOS.
- To ensure timely completion of the self and subordinated assigned trainings.
- To participate in the Change Control Pre- Assessment meetings and perform the impact assessment of the assigned change controls in Trackwise.
- To review and approve the scheduled validation activity as per monthly calendar and send it to the cross functional & Planning department in advance for execution planning before the scheduled date.
- To ensure implementation of validation, qualification activities & inform HOD for any non-conformity deviated from written procedure.
- To ensure timely/contemporaneous (wherever applicable) data recording and compilation of reports during execution.
- To co-ordinate with projects and other cross functional departments. for prior information on new equipment installation and review respective protocol in TcU followed by qualification of new equipment and get it approved by HOD.
- To review summary report for submission to International Regulatory Affairs (IRA) as a part of queries or ANDA submission.
- To guide and coach team for protocol creation, planning & execution & preparation of validation report.
- To ensure compliance with validation/qualification requirements as per regulatory requirements and to update the documents to meet the expectations.
- To ensure SOPs/ Protocols are in-line with regulatory and Baxter Global Requirements (GQRs) and Procedure (GQPs).
- To update, review and approve Validation Master Plan in compliance to regulatory requirement and site validation policy.
- To escalate the activity or issues which might occur during second and night shift validation activities to HOD.
- To escalate any potential challenges for execution of any validation /qualification activities.
- To participate during any internal or external inspection and prepare the audit response.
- To prepare shift schedule as per the validation activity and ensure business needs are fulfilled on time.
- To be vigilant of safety aspects and record hazard or any near miss in the provided portal. To assist the department, lead for the preparation of the budget and ensure the expenses as per allocated budget.
- To intimate Production & Production Planning and Availability (PPA) department in advance for process validation & qualification activities.
- To review and approve documents related to Validation activities and other documents related to Operation.
