Sr Spec, Quality Compliance at Baxter International

Ahmedabad, Gujarat, India

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Expertise in Internal Audits, External Audits, Audit readiness, Regulatory Intelligence, and Global Observation Certification
Knowledge of compliance with Baxter policies, procedures, and regulatory requirements, including cGMP
Proficiency in maintaining internal audit schedules and performing quality audits
Ability to perform system and facilities reviews per regulatory requirements
Skills in verifying processes and systems against SOPs and regulatory standards
Experience assisting in hosting external inspections and coordinating cross-functional audit responses
Capability to arrange audit prerequisites, agendas, and handle ongoing inspection requests
Competence in ensuring audit commitments compliance and effectiveness
Familiarity with QMS elements in Trackwise for tracking and closing audit commitments
Knowledge of ensuring all-time site readiness for regulatory audits and inspections
Ability to establish policies, processes, and metrics aligned with business strategy and regulations
Strong communication and coordination skills with cross-functional teams and SLTs
Proficiency in approving Document Change Requests (DCR), Change Control Management (CCM), Non-conformance, CAPA, and other QMS elements using Team Center Unify (TCU) and related tools
Experience conducting GEMBA walks and mitigating observations
Skills in compliance verification for regulatory intelligence gap assessments, global observation certification, quality alerts, and corporate holds
Ability to partner with Regulatory Affairs for cGMP application support
Oversight of Quality KPIs, performance reporting to QMR and MWER, and driving improvements with cross-functional teams
Knowledge of cGMP compliance based on inspection trends and promoting regulatory/customer awareness
Expertise in reviewing, approving/rejecting QMS elements, ensuring timely closures and CAPA effectiveness
Commitment to data integrity maintenance and ensuring systems are in a state of control
Ability to partner with leaders to foster a quality culture, processes, and practices for business scalability

Responsibilities

Maintain the schedule of internal audits and perform internal quality audits to ensure compliance with quality systems and procedures
Perform system and facilities reviews to support all-time readiness for internal/external audits
Verify processes and systems comply with SOPs and current regulatory requirements
Assist Compliance Head or Site Quality Head in hosting external inspections and facilitating audit compliance responses with cross-functional departments
Arrange pre-requisites, audit agendas, and handle ongoing inspection requests
Ensure audit commitments are compliant and effective
Handle QMS elements in Trackwise to track and close audit commitments within timelines
Ensure all-time readiness of the site for regulatory audits and inspections
Establish clear policies, processes, and metrics aligned with business strategy and regulatory requirements
Communicate and coordinate with cross-functional teams and SLTs on Compliance, QMS, and Inspection Management activities
Approve Document Change Requests (DCR), Change Control Management (CCM), Non-conformance, CAPA, and other QMS elements; prepare/review documents using TCU and applicable tools
Perform GEMBA walks and ensure mitigation of observations
Verify compliance for regulatory intelligence gap assessments, global observation certification, quality alert assessments, corporate hold assessments, etc
Partner with Regulatory Affairs to provide site-related information and documents for cGMP applications
Oversee Quality KPIs, improve scores with cross-functional teams, and report QMS performance and improvements to QMR and MWER
Ensure cGMP compliance status per regulatory requirements and trends; promote awareness of regulatory and customer requirements
Review, approve, or reject QMS elements and actions; ensure timely closure and effectiveness of CAPAs at departmental level
Ensure data integrity is maintained at all levels and systems are in a state of control
Partner with leaders and team members to establish a clear, consistent, efficient quality culture, processes, and practices enabling business scalability

Skills

Trackwise

Internal Audits

External Audits

Audit Readiness

Regulatory Intelligence

Regulatory Compliance

SOPs

QMS

Quality Audits

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

Land your dream remote job 3x faster with AI

Try Jobo Free