Sr Exec, Quality 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.

• To ensure availability of Impurity and Standards used in Quality Control and Stability laboratory.
• To ensure procurement and installation of analytical instruments in Quality Control and Stability laboratory.
• To collaborate with other stakeholders for installation of analytical instruments.
• To ensure and train team members on current good manufacturing practices (GMP), Good Documentation Practices and good laboratory practice (GLP).
• To take participation in  any Out of specifications (OOS) or Non-conformity Report or Laboratory Incident and take the corrective and preventive actions (CAPA) if required
• To support external audit process as per role assigned by Quality Control Operation Head or Quality Control and Stability head
• To provide the response to the internal and external audit observations and ensure their closure.
• To provide technical and regulatory guidance to stakeholders to ensure overall quality and compliance.
• To share observations various inspections and follow up with stakeholders for holistic implementation of CAPA.
• To Co-ordinate consultant visit and/or Mock Audit at site as part of Inspection Readiness
• To perform gap assessment of Procedure vs Practices.
• To perform the task as assigned by Supervisor.
• To ensure that quality control laboratory and Stability system and facilities are complying to regulatory requirements and expectations.
• To be responsible to bring all the observed issues/gaps related to compliance/process on table and independently report to Supervisor .
• To come out with the suggestion on further enhancement for quality control laboratory and Stability system and facilities.
• To work with Analysts and Reviewers to implement compliant GMP and Good Documentation Practice (GDP) practices, review issues and impact of the same, and take corrective actions.
• To perform the calibration of all the instruments, perform as per the schedule.
• To report and escalate as appropriate critical non-conformances immediately to Supervisor.
• To work for lab readiness for audit and ensure compliance in Laboratory.
• To come out with the suggestion on further enhancement for laboratory system and facilities.
• To ensure the laboratory compliance in line with regulatory guideline and requirements.
• To support external audit process as per role assigned by Supervisor.
• To co-ordinate with service engineer and lab maintenance team for upkeep of analytical instruments.
• To perform daily and biweekly laboratory walk-through and as needed reviews to monitor and maintain sustained GMP compliance.
• To ensure data integrity is maintained in laboratory.
• To take suggestions from Quality Control and Stability head regarding CAPA (Corrective and Preventive Action) as per requirement and ensure its implementation and execution within stipulated timeframe and effectiveness of CAPA.
• To ensure implementation of change control management (CCMs), Document Change Request (DCR) wherever necessary after getting it approved from QA.
• In the absence of Team, Supervisor will ensure these roles and responsibilities.
• To prepare SOPs and Standard Formats for executing QC & Stability work ensuring these are current and meet company and international regulations.
• To be involved in Investigations Management of OOSs, OOTs, LIRs, Deviations, CCNs, Customer Complaints, CAPA.
• To bring to the notice about any abnormalities and non-conformity to Quality Control and Stability Head.
• To perform any other task assigned by Supervisor or Quality Control and Stability Head.

Reasonable Accommodations

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