Mgr, Quality

2 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 direct Central Quality function to establish clear policies, processes and metrics are in line with the Business strategy and Regulatory requirements which are instrumental in driving consistency and compliance. To oversee Quality Key Performance Indicators (KPI) and improve the scores in liaison with Cross Functional Teams. To ensure that Data integrity is being maintained at all level and to perform / get performed regular checks to ensure that system is in state of control. To partner with the Leaders and Team Members to establish clear, consistent and efficient quality culture, processes and practices at site. Enabling scalability of the business while ensuring quality and compliance in product manufacturing life cycle. As part of Quality Integration Plan (QIP), to oversee integration of Baxter Quality Procedures (GQR/GQPs) and Baxter Quality IT systems (Trackwise, TCU, CFS, BaxU etc). To ensure site procedures are inline to the requirements through adequate Gap Assessments. To ensure that Management Review (MRs) meetings are scheduled, conducted and maintained in accordance with the Standard procedure. To appraise QMR about functioning of Quality systems and elevate issues or concerns, as required. 2.8 Quality Management Systems: 2.8.1 To ensure integrity of the Quality Management Systems (QMS) when changes to the QMS are planned and implemented. 2.8.2 To give inputs and oversee the functioning of Central Quality Systems, i.e. Doc. Cell, Training & Development, Supplier Quality, QMS, Product Quality Review, Artworks, Market Complaint, Compliance, Inspection. 2.8.3 To lead QMS review meetings, such as CAPA Review Board (CRB), Management Review (MR) etc. and ensure its timely execution. To track action items as an outcome of these review meeting. 2.8.4 To ensure timely closure of QMS elements and effectiveness of the implemented CAPAs at departmental level. 2.8.5 To ensure field surveillance activities, such as Product Hold, Field action and Product recall are being executed and appraised to the Leadership team; to approve the same as a Delegated responsibility of QMR. 2.8.6 To liaise with Vendors/ Suppliers for effective CAPA plan on audit observations/ concerns in terms of SNCs. To ensure adequate and timely closure of Supplier Corrective Action Request (SCAR). 2.8.7 To oversee Documents archival & Retrieval Management is effective. 2.8.8 To oversee that the required initial (onboarding) and continuing training of site personnel is carried out and adapted according to the need. 2.9 External Inspection Management & Compliance: 2.9.1 To ensure the CGMP compliance status of site as per the regulatory requirements and expectations based on the current inspection/ industrial trends as a Continuous improvement. 2.9.2 Ensuring all audit/ inspection activities are documented, communicated, and tracked, including (when appropriate) records of correspondence/meetings with regulatory agencies, verbal commitments, commitments described in submitted responses, appending or offsite reviews and responses, and status updates to/from regulatory agencies. 2.9.3 To ensure the promotion and awareness of regulatory and customer requirements throughout the organization. 2.9.4 To lead correspondence with regulatory bodies and partners to update site’s license renewals, inspection commitments, major updates at site and filing of new products. 2.9.5 To ensure timely response to audit observations and recommendations by liaising with different functions at site for holistic implementation of CAPA actions. 2.9.6 To mentor and develop SMEs for all time audit readiness, education on regulatory guidelines, systems and processes. 2.10 Administrative: 2.10.1 To ensure appointment of qualified staff, their technical and overall development through systematic training processes and reviewing their performance periodically. 2.10.2 To oversee and monitor Quality functions and suggest inputs time to time. 2.10.3 To communicate KPI scores with stake holders. 2.10.4 To ensure the availability of necessary resources, infrastructure, instruments to carry-out the day-to-day functions. 2.10.5 To act as a liaison between global team and the functional representatives in the department. 2.10.6 To maintain departmental budget and monitor on periodic basis.

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