Supr, QA Q&v

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.

2.1 To review executed protocols of equipment, utility, process validation, cleaning validation, Utility and facility /HVAC qualification.

2.2 To coordinate with cross functional departments for execution of all validation activities & escalate to Manager regarding any non-conformity from planning.

2.3 To review calendars for various periodic qualification & get it reviewed and approved by Manager.

2.4 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.

2.5 To ensure timely closure of the DCRs, CCM tasks, investigation report due to any NCR/OOS.
2.6 To ensure timely completion of the self and subordinated assigned trainings.
2.7 To participate the Change Control Pre

  • Assessment meetings and perform the impact assessment of the assigned change controls in Trackwise.

2.8 To review and approve the scheduled validation activity as per monthly calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.

2.9 To ensure implementation of validation, qualification activities & inform to Manager for any non-conformity deviated from written procedure.
2.10 To ensure timely/contemporaneous (wherever applicable) data recording and compilation of reports during execution.
2.11 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 Manager.

2.12 To review summary report for submission to International Regulatory Affairs (IRA) as a part of queries or ANDA submission.

2.13 To guide and coach team for protocol creation, planning & execution & preparation of validation report.

2.14 To ensure compliance of validation/qualification requirements as per regulatory requirements and to update the documents to meet the expectations.

2.15 To ensure SOPs/ Protocols are in-line with regulatory and Baxter Global Requirements (GQRs) and Procedure (GQPs).

2.16 To update, review and approve Validation Master Plan in compliance to regulatory requirement and site validation policy.
2.17 To escalate the activity or issues which might occurred during second and night shift validation activities to Manager.
2.18 To escalate any potential challenges for execution of any validation /qualification activities.
2.19 To participate during any internal or external inspection and prepare the audit response.
2.20 To prepare shift schedule as per the validation activity and ensure business need is fulfilled on time.
2.21 To be vigilant for safety aspects and record hazard or any near miss in the provided portal. To assist department, lead for the preparation of the budget and ensure the expenses as per allocated budget.
2.22 To intimate Production & Production Planning and Availability (PPA) department in advance for process validation & qualification activities.
2.23 To review and approve the documents related to Validation activities and other documents related to Operation.
2.24 To act as designee in absence of Manager.
2.25 To ensure that healthy work environment prevails in the validation section.
2.26 Any additional responsibility as assigned by manager.

Reasonable Accommodations

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